The warning comes following the death of a preterm infant who was administered Evivo with MCT Oil, a probiotic formulated with live bacterium Bifidobacterium longum subsp. infantis, as part of in-hospital care. Genomic sequencing data confirmed that the bacterium that caused sepsis in the child was a genetic match to the bacteria contained in the probiotic.

Though the FDA is aware that some unlicensed probiotics are being used to treat infants, these products have not been evaluated for safety or effectiveness in this vulnerable population. Administering products with live bacteria or yeast to preterm infants can result in potentially fatal disease. According to a clinical report published by the American Academy of Pediatrics, “current evidence does not support the routine, universal administration of probiotics to preterm infants, particularly those with a birth weight of less than 1000g.”

Health care providers who administer probiotics containing live bacteria or yeast as a treatment are required to submit an Investigational New Drug Application to the FDA. Adverse events should also be reported to the FDA’s MedWatch Program.

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Patients with FEDs often have a high rate of comorbidity with other psychiatric and medical issues, suggesting the need for a multidisciplinary approach to treatment. Among these therapeutic approaches, educational interventions have gained increased attention for the specific and concrete strategies that provide skills to patients in managing their disorder. With this in mind, the review authors aimed to assess the effect of educational interventions on adolescents with FEDs.

The review authors conducted this systematic review by searching the databases of Scopus, Cochrane Library, ENFISPO, DIALNET, CUIDEN, PsycINFO, CINAHL, and PubMed through June 2023 for articles in English or Spanish related to educational interventions in a young population diagnosed with anorexia nervosa, avoidant/restrictive food intake disorder, bulimia nervosa, pica and ruminative disorders, and binge-eating disorder. Additionally, reviewers searched grey literature on OpenGrey and Teseo.

Included studies were of quasi-experimental or experimental design that assessed the efficacy of educational interventions in patients with FEDs, aged 12 to 18 years. Studies with anorexia as a symptom (defined as lack of appetite or appetite affected by multiple causes) due to underlying disease were excluded, along with publications in which interventions were directed exclusively at families or support groups. These criteria yielded 10 publications that evaluated the impact of a variety of learning techniques and educational interventions on FEDs in a total of 517 participants.

The studies evaluated in the review measured the effects of educational interventions on learning, improved nutritional knowledge, and positive mental changes toward food/eating. In 4 studies, educational intervention was associated with weight gain in patients and some studies reported decreases in the frequency of vomiting, binge-eating, and purging. Results across studies also show a general trend of more normalized eating patterns following intervention. Furthermore, educational intervention was associated with increased cognitive flexibility in 1 comparative study.

However, the studies included had a wide variability in educational methodologies and assessed outcomes using different tools, making current review comparisons difficult. Risk of bias was also high due to the low methodological quality found in these articles. A small sample size was cited in 6 studies and the vast majority of articles (n=9) only examined FEDs in girls. The heterogeneity in outcome evaluation, groups vs individual settings, and the interventions themselves limit the ability to make clinical recommendations as to therapeutic impact.

Though the authors indicated that educational interventions seem to improve patient knowledge and have a positive effect on health outcomes, the incongruous study elements necessitate further research to robustly support this therapy. The reviewers concluded, “Only by obtaining a deeper understanding, can we generalize our results beyond current studies and provide constructive information for the design of educational programs aimed at this population.”

This review was limited by the inclusion of studies with varying methodological quality and evidence levels, as this significant heterogeneity did not allow for meta-analysis.

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Researchers evaluated the impact of RCV on global CRS incidence in a systematic review. The researchers identified age-stratified data on rubella seroprevalence from previous research published from January 2012 to September 2020. Age-specific fertility rates, total number of live births from 1996 to 2019, and survival data were identified from participating countries via United Nations’ population databases. Countries in which RSV had been introduced were divided into World Health Organization (WHO) regions, and annual vaccination data were obtained from country-specific submissions. 

A total of 129 datasets from 70 countries were assessed to estimate the global CRS burden. Four catalytic models were used to evaluate seroprevalence data and calculate the mean age-specific prevaccination force of infection (ie, rate at which susceptible individuals are infected). The models were designed with the assumption that prevaccination force differed between individuals younger than 13 years and those 13 years and older. A transmission model was used to calculate the incidence of CRS per 100,000 live births and the annual number of infants born with CRS from 1996 to 2019. The transmission model also was designed to stratify populations by maternal immunity and by those who were susceptible, pre-infectious, infectious, and immune.

In 2019, the highest estimated regional CRS incidence per 100,000 live births was noted in the African region (64; 95% CI, 24-123), followed by the Eastern Mediterranean region (27; 95% CI, 4-76). Of note, the incidence of CRS in the African region decreased from 119 (95% CI, 62-209) to 64 (95% CI, 24-123) between 2012 and 2019.

Of 22 countries where RCV was not introduced by 2019, 17 were in in the African region (17% of global live births) and 5 were in the Eastern Mediterranean region (7% of global live births). Further analysis of the African region showed that South Africa had an estimated CRS incidence of 36 (95% CI, 2-93), whereas Nigeria had an estimated incidence of 130 (95% CI, <1-337). In the Eastern Mediterranean region, the estimated CRS incidence ranged from 50 (95% CI, <1-173) in Pakistan to 91 (95% CI, <1-202) in Sudan.

Low CRS incidence was observed in countries where RCV had been introduced. The estimated incidence of CRS was less than 1 in both the Western Pacific and Southeast Asian regions, as more than 95% of births had occurred following the introduction of RCV. 

The estimated global number of annual CRS diagnoses was 121,000 (95% CI, 70,000-191,000) in 2010. However, after the introduction of RCV, the estimated global number of annual CRS diagnoses decreased to 32,000 (95% CI, 13,000-60,000) by 2019, representing an overall reduction of 73% from 1996 to 2019. The highest estimated number of CRS diagnoses in 2019 were noted among Ethiopia, Republic of the Congo, Niger Pakistan, Nigeria, Uganda, and Sudan, with more than 1000 diagnoses annually.

Following the introduction of RCV, an estimated 229,000 (95% CI, 131,00-368,000) diagnoses of CRS have been averted. The highest number of averted CRS diagnoses was observed in the Southeast Asian region (125,000; 95% CI, 37,000-111,000).

Limitations of this study include the lack of seroprevalence data for certain countries, as well as the possibility that some datasets were not representative of surveyed populations. Moreover, the reduction in the transmission and incidence of CRS may have been overestimated.

According to the researchers, “With sustained coverage and the introduction of RCV into the remaining countries where it has not yet been introduced, further reductions are possible.”

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The systematic review and meta-analysis assessed the common clinical manifestations of RSV infection by age group and human development index (HDI) level as well as the association between RSV infection and wheezing or recurrent wheezing illness.

A literature search for relevant articles published between January 1, 2010, and June 2, 2022, was performed in 7 databases. Eligible studies reported common clinical manifestations of RSV-infected children aged 5 years of age or younger. Common clinical manifestations were evaluated with pooled estimates of 1-group meta-analyses, and the ratio-based effect was estimated for children with and without RSV infection who had wheezing.

Among the 47 included studies, 35 reported clinical manifestations of RSV infection in 24,822,974 participants. An association between RSV infection and wheezing illness was reported in 7 studies (3035 participants), and 7 studies (228,301 participants) found an association between early childhood RSV infection and recurrent wheezing illness.

The pooled incidence of mild clinical manifestations was 51%, which was significantly higher than moderate (37%) and severe (7%) clinical manifestations. Cough was the most frequently occurring mild clinical manifestation (92%), followed by nasal congestion (58%), rhinorrhea (53%), and fever (41%). The most common severe clinical manifestation was respiratory failure (29%), followed by sepsis (10%).

In children aged 0 to 1 year, the pooled incidences of mild, moderate, and severe clinical manifestations were 55%, 50%, and 9%, respectively. Clinical manifestations associated with RSV included cough (90%), shortness of breath (60%), and need for oxygen supplementation (54%). The pooled incidences of mild, moderate, and severe clinical manifestations in those aged 0 to 2 years were 51%, 39%, and 6%, respectively. The most common RSV-associated clinical manifestations were cough (93%), shortness of breath (57%), and fever (45%).

Among countries with very high HDI, the pooled incidences of mild, moderate, and severe clinical manifestations were 56%, 25%, and 6%, respectively. For countries with high HDI, the pooled incidences of mild, moderate, and severe clinical manifestations were 49%, 47%, and 5%, respectively. For medium-HDI countries, the pooled incidences of mild and moderate clinical manifestations were 76% and 31%, respectively. No data were available for low-HDI countries.

The association between RSV infection and wheezing was evaluated in 7 studies. Participants who were RSV-positive were more likely to have wheezing vs the control group (odds ratio [OR], 3.12; 95% CI, 2.59-3.76).

The association between early childhood RSV infection and subsequent recurrent wheezing illness was investigated in 7 studies. The RSV-positive group was more likely to have recurrent wheezing illness compared with the control group (OR, 2.60; 95% CI, 2.51-2.70).

The researchers noted that their analysis was based on a limited number of studies, resulting in large confidence intervals. Also, different methods were used to assess the outcomes, a subanalysis was not performed on all clinical manifestations, and substantial heterogeneity occurred in the studies for the association between RSV infection and recurrent wheezing. “Respiratory tract infection symptoms, such as cough and shortness of breath, are the most common clinical manifestations of RSV infection, and the incidence of fever is low,” concluded the researchers. “This suggests that surveillance based on the influenza-like illnesses, which takes fever as the surveillance symptom, might not be a suitable surveillance strategy for identifying patients with RSV infection.”

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Helene Rietz, M.D., from Umeå University in Sweden, and colleagues measured the association between BP in adolescence and future cardiovascular events in a cohort study involving males in late adolescence who were conscripted into the military from 1969 to 1977. Data were included for 1,366,519 males (mean age, 18.3 years).

The researchers found that baseline BP was classified as elevated (120 to 129/<80 mm Hg) and hypertensive (≥130/80 mm Hg) for 28.8 and 53.7 percent of participants, respectively. Overall, 79,644 participants had a primary outcome (composite of cardiovascular death or first hospitalization for myocardial infarction, heart failure, ischemic stroke, or intracerebral hemorrhage) during a median follow-up of 35.9 years. The adjusted hazard ratios were 1.10, 1.15, 1.23, 1.32, 1.31, 1.55, and 1.71 for elevated BP, stage 1 isolated systolic hypertension (ISH), stage 1 isolated diastolic hypertension (IDH), stage 1 isolated systolic-diastolic hypertension (SDH), stage 2 ISH, stage 2 IDH, and stage 2 SDH, respectively. Across BP stages, the cumulative risk for cardiovascular events also increased gradually, from 14.7 percent for normal BP to 24.3 percent for stage 2 SDH at age 68 years.

“These findings suggest that early detection and treatment of hypertension might reduce risk for future cardiovascular events,” the authors write.

Abstract/Full Text 

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Researchers sought to assess the temporal association between COVID-19 infection and the development islet autoimmunity — a precursor for type 1 diabetes — in early childhood. Between April 2019 and June 2022, 885 infant participants (441 girls; age range, 4.0-7.0 months) with high genetic susceptibility to type 1 diabetes were evaluated, all of whom tested negative for islet autoantibodies at baseline. Participants were included if their estimated risk of developing multiple islet autoantibodies was at least 10% by the age of 6 years. Participants were randomly assigned to receive either oral insulin powder or placebo, administered daily until 3 years of age.

Blood samples were collected from all participants from baseline until 6.5 years of age. Participants also were screened for immunoglobulin G SARS-CoV-2 antibodies, influenza A antibodies, and islet autoantibodies. The presence of autoantibodies against insulin, glutamate acid decarboxylase 65 (GAD65), insulinoma-associated antigen 2 (IA-2), and zinc transporter 8 (ZnT8) served as positive biomarkers for islet autoantibodies.

The primary outcome was either the development of persistent autoantibodies against insulin; GAD65; IA-2; or ZnT8 in 2 consecutive samples and a confirmed second antibody in 1 sample or 1 or more of the antibodies and diabetes. Maternally transferred antibodies were excluded from analysis. The incidence rates (IRs) of antibodies and autoantibodies were compared between groups via chi-squared testing. Cox proportional hazards models were used to assess covariates associated with islet autoantibody development in participants with confirmed SARS-CoV-2 antibodies.

Overall, 170 participants developed SARS-CoV-2 antibodies at a median age of 18 (range, 6-25) months. The IR of positive SARS-CoV-2 antibodies per 100 person-years was 0 from February 2018 to June 2020; 4.4 from July 2020 to December 2020; 21.5 from January 2021 to June 2021; 9.2 from July 2021 to December 2021; and 81.7 from January 2022 to June 2022.

Of note, the incidence rate per 100 person-years of the first development of influenza A antibodies was insignificant throughout the trial period (P =.63).

Further analysis showed islet autoantibodies had developed in 60 participants by 30 months of age, with a cumulative frequency of 6.8% (95% CI, 5.3-7.6). All 60 participants tested positive for islet autoantibodies until the final follow-up visit, and 33.3% developed type 1 diabetes. The rate of islet autoantibody development was significantly higher among participants who tested positive (IR, 7.8 per 100 person-years; 95% CI, 5.3-19.0) vs negative (IR, 3.5 per 100 person-years; 95% CI, 2.2-5.1) for SARS-CoV-2 antibodies (both P =.02).

After adjustments for sex, age, and country in a time-dependent Cox model, SARS-CoV-2-antibody positivity was significantly associated with increased risk for islet autoantibody development (hazard ratio [HR], 3.5; 95% CI, 1.6-7.7; P =.002). For the development of islet autoantibodies within 6 months, the cumulative risk was significantly higher in participants who were positive (7.3%; 95% CI, 4.2-12.7) vs negative (2.9%; 95% CI, 1.8-4.8) for SARS-CoV-2 antibodies (both P =.01).

Factors significantly associated with increased risk for islet autoantibody development included the detection of SARS-CoV-2 antibodies prior to 18 months of age (HR, 5.3; 95% CI, 1.5-18.3; P =.009).

Study limitations were the inclusion of only participants with high genetic susceptibility to type 1 diabetes, the inability to confirm COVID-19 infection via polymerase chain reaction, and the low number of participants who developed islet autoantibodies. The researchers also were unable to exclude possibility of reverse causality, as children who develop islet autoantibodies may be more susceptible to COVID-19 infection.

According to the researchers, “The age of SARS-CoV-2 infection appeared to be critical in the association with islet autoimmunity.”

Disclosure: One study author declared affiliations with industry. Please see the original reference for a full list of disclosures.

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Researchers at the University of Calgary in Alberta, Canada conducted a cross-sectional, population-based, observational study, obtaining data from the 2019 Canadian Health Survey on Children and Youth between the ages of 12 and 17. Participants answered survey questions regarding sex assigned at birth, current gender identification, socioeconomic status based on annual household income, headache frequency, overt and relational bullying frequency, and suicidal ideation.

In the sample of 2,268,840 participants (mean age, 14.4), 48.8% identified as girls, 50.7% identified as boys, and 0.5% identified as gender diverse. A total of 11.2% of all participants reported frequent recurrent headaches.

Factors correlating with frequent recurrent headaches included older age (odds ratio [OR], 1.26; 95% CI, 1.20-1.31), female sex (OR, 2.89; 95% CI, 2.47-3.37), and gender diversity (OR, 3.30; 95% CI, 1.64-6.63). Compared with peers without frequent recurrent headaches, adolescents reporting frequent headaches were also more likely to experience bullying that was either overt (OR, 2.69; 95% CI, 2.31-3.14) or relational (OR, 3.03; 95% CI, 2.58-3.54).

After adjusting for age and sex, the researchers found that frequency of headaches were correlated with overt (adjusted OR, 1.82; 95% CI, 1.41-2.34) and relational (aOR, 1.54; 95% CI, 1.17-2.03) bullying but were not correlated with gender diversity alone (OR, 1.53; 95% CI, 0.69-3.69). The researchers suggest that the psychosocial factors associated with gender diversity may explain this discrepancy.

Other psychological factors that correlated with increased headache recurrence included suicidal ideations (aOR, 1.83; 95% CI, 1.44-2.32) and diagnosis with either an anxiety disorder (aOR, 1.74; 95% CI, 1.24-2.45) or a mood disorder (aOR, 1.50; 95% CI, 1.01-2.21). After adjusting for mood and anxiety disorders along with sex and age, the researchers found that suicidal ideation increased with headache frequency.

Study limitations included the cross-sectional design, lack of temporality preventing conclusions on causality, lack of generalizability to understudied populations, the risk for measurement bias due to retrospective self-report, and unmeasured confounding variables, such as genetics or secondary headache causes. Additionally, the large sample size and lack of a priori sample size calculations may lead to clinically insignificant findings.

“Peer victimization and suicidality may be associated with higher headache frequency in adolescents with headaches, independently of mood and anxiety symptoms,” the researchers wrote. “Gender diverse adolescents may have a higher risk of experiencing frequent headaches as compared to cisgender peers…explained by associated psychosocial factors.”

Disclosures: Several study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Researchers conducted a systematic review and meta-analysis to assess the effects of COVID-19 pandemic lockdown measures on pediatric asthma morbidity. The review included prospective or retrospective observational cohort studies published between January 2020 and August 2022, avoiding studies based on administrative data.

The meta-analysis included 11 studies with 5490 participants (51% to 72.8% male; mean age range, 8.4 to 13.47 years).

Studies evaluating asthma symptom control showed a statistically significant increase in the mean childhood Asthma Control Test (c-ACT) score during the lockdown period (standardized mean difference [SMD], 1.99; 95% CI, 0.75-3.24). Additionally, 4 studies observed changes in the proportion of patients with well-controlled asthma, while 5 noted changes in the proportion of patients with poorly controlled asthma. The pooled proportion of patients with well-controlled asthma increased during the lockdown period (pooled relative risk [RR], 1.35; 95% CI, 1.06-1.71). Conversely, the pooled proportion of patients with poorly controlled asthma decreased (pooled RR, 0.47; 95% CI, 0.38-0.57).

A change in the proportion of patients who experienced asthma exacerbations was reported by 2 studies. In 1 study, asthma exacerbations decreased from 10.9% before the lockdowns to 4.9% during the lockdown period. Another study showed a nonstatistically significant incidence rate ratio (IRR) of 0.89 for exacerbations.

In 4 studies, consistent findings were reported regarding a decrease in emergency department (ED) visits during COVID-19 lockdowns. In 1 study, researchers found a 69% reduction in the number of visits; in another, ED visits decreased from 34.4% in 2019 to 11.0% in 2020. Fewer hospitalizations were also consistent across 3 studies, with 1 study reporting a 76% reduction in the number of hospitalizations.

Notably, quantitative synthesis was not possible for other endpoints such as asthma symptoms severity, asthma-related quality of life, unscheduled or acute or general outpatient or clinician visits, and asthma medication use or treatment due to a low number of studies; however, an overall improvement in asthma symptoms and severity during lockdown was observed in all studies that addressed these endpoints.

Study limitations include a reliance on aggregate estimates from included studies and heterogeneity observed across different outcomes.

“In this systematic review and metanalysis, we have shown that pediatric asthma symptoms control, asthma exacerbations, ED visits, hospitalizations, and other endpoints such as asthma medication use or treatment adherence were significantly improved during the COVID‐19 lockdowns compared to the period before them,” said the study authors. “After the pandemic, public health measures can be considered with the aim to produce a similar cumulative beneficial effect on asthma control,” the researchers added.

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Byron A. Foster, M.D., from the Oregon Health & Science University in Portland, and colleagues examined weight trajectories for school-aged children with a focus on obesity remission. The analysis included 11,247 children (6 to 11 years of age) with three or more valid height and weight measurements from an Oregon hospital system during Jan. 1, 2015, through Sept. 30, 2020, followed for a median of 2.1 years.

The researchers found that 14.4 percent of children were classified as overweight and 16.0 percent as obese. During follow-up, 1 percent of participants with obesity experienced remission, while 23 percent of those with overweight moved to within a healthy weight range. Three classes (flat trajectory, flat trajectory with a different intercept, flat then upward trajectory) within each weight-based stratum were identified over time. Most children with overweight or obesity had a flat trajectory over time. A worsening trajectory was associated with lower socioeconomic status. Models using different adiposity metrics (body mass index [BMI], BMI z-scores, tri-ponderal mass index) differed substantially from each other.

“Further weight trajectory modeling work using distance from the median with longer periods of follow-up and incorporating additional clinical indicators in addition to BMI to characterize metabolic health are warranted using these types of data,” the authors write.

Abstract/Full Text

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Researchers investigated outcomes of MIST in 2-year-old children (corrected age) born preterm with respiratory distress syndrome who were receiving CPAP therapy, comparing this intervention with sham treatment. Primary outcomes of interest were the incidence of death or moderate to severe NDD at 2-years corrected age; the effect of MIST vs sham treatment on adverse respiratory outcomes was also assessed.

The researchers conducted a follow-up study of OPTIMIST-A (ClinicalTrials.gov Identifier: NCT02140580), a randomized clinical trial of 486 infants with a gestational age of 25 to 28 weeks who were admitted to the neonatal intensive care unit for respiratory insufficiency and were subsequently intubated. Infants with another respiratory disease or serious congenital disorder were excluded from the study. Children treated with MIST (n=242) received a dose of 200 mg/kg poractant alfa intratracheally; children in the control group (n=244) received a sham treatment (ie, transient repositioning only).

Outcome data was collected via in-person follow-up assessment at 2 years corrected age, with an online questionnaire administered for children who were unable to do an in-person follow-up. NDD was defined as moderate to severe cognitive or language impairment, cerebral palsy equivalent to the Gross Motor Function Classification System level of 2 or higher, visual impairment, or hearing impairment. Relative risk (RR) was calculated to compare poractant alfa treatment with the sham treatment and was adjusted for gestational age.

Researchers found that 29 infants treated with MIST and 24 infants treated with sham treatment died at 2 years corrected age. Although the RR of death between the treatment and control group was 1.23, it was insignificant (95% CI, 0.69-2.19; P =.48). The relative difference (RD) in death between the 2 groups was also insignificant (RD, 2.4%; 95% CI, -3.6% to 8.4%).

Among the children who survived, 186 in the MIST group and 195 in the control group were fully assessed for NDD at 2 years corrected age. NDD occurred in 49/186 of children in the MIST group and 55/195 children in the control group. The RR and RD of developing NDD was also insignificant by 2 years corrected age (RR, 0.94; 95% CI, 0.71-1.25; RD, -1.6%; 95% CI, -9.4% to 6.2%; P =.69).

Notably, infants treated with MIST had a significantly lower relative reduction of 34% in the frequency of 1 or more hospitalizations for respiratory illness than the control group (MIST group vs control group, 25.1% vs 38.2%; RR, 0.66; 95% CI, 0.54-0.81; P <.001). Infants treated with MIST also had a 24% relative reduction in wheezing or breathing difficulty, compared with the control group (MIST group vs control group, 40.6% vs 53.6%; RR, 0.76; 95% CI, 0.63-0.90; P =.002).

Study limitations include use of an online questionnaire as the dominant method of data collection and the limited sample size. Additionally, the original clinical trial was not designed to detect differences in 2-year outcomes or to assess some of the comparisons made in this follow-up study.

Overall, researchers concluded that “MIST compared with sham treatment did not reduce the incidence of death or NDD by 2 years of age. However, infants who received MIST had lower rates of adverse respiratory outcomes during their first 2 years of life.”

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Anna Ek, Ph.D., from the Karolinska Institutet in Stockholm, and colleagues examined weight status 48 months after obesity treatment initiation for 4- to 6-year-olds from 177 families recruited to the More and Less study 12-month randomized controlled trial. Overall, 171 families were eligible for 48-month follow-up; 114 had 48-month data. Three treatment approaches were compared: a 10-week parent-support program with follow-up booster sessions (PGB) or without (PGNB) and standard outpatient treatment (ST).

The researchers found that after 48 months, the mean body mass index standard deviation score (BMI-SDS) was reduced in all groups: −0.45, −0.34, and −0.25 for PGB, PGNB, and ST, respectively, with no significant between-group differences noted. A clinically significant reduction of ≥0.5 of BMI-SDS occurred in 53.7 and 33.0 percent of the PGB and ST groups, respectively (risk ratio, 2.03); no significant difference was seen between ST and PGNB (46.6 percent). The percentage above the International Obesity Task Force overweight cutoff was unchanged from baseline for PGB and significantly lower for PGB versus ST.

“The children in all three groups improved their weight status and saw a reduction in their degree of obesity,” principal author Paulina Nowicka, Ph.D., also from the Karolinska Institutet, said in a statement. “The children whose parents received parental support had the best results, especially those who also received follow-up phone calls.”

Abstract/Full Text

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Robin Mzati Sinsamala, from University of Bergen in Norway, and colleagues used data from 4,286 children and their mothers living in five European countries (Denmark, Norway, Sweden, Iceland, and Estonia) participating in the Respiratory Health in Northern Europe study to investigate the association of maternal exposure to air pollution and greenness during pregnancy with birth weight and preterm birth.

The researchers found that higher levels of air pollution were linked to lower birth weights. Specifically, particulate matter (PM_2.5 and PM₁₀), nitrogen dioxide, and black carbon were associated with average reductions in birth weight of 56, 46, 48, and 48 g, respectively. However, when accounting for greenness, the effect of air pollution on birth weight was reduced. Compared with mothers living in less green areas, women who lived in greener areas had babies with slightly higher birth weights (27 g heavier on average).

“The time when babies are growing in the womb is critical for lung development,” Sinsamala said in a statement. “We know that babies with lower birthweight are susceptible to chest infections, and this can lead on to problems like asthma and chronic obstructive pulmonary disease later on.”

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Investigators evaluated the effects of obesity on height for age, height velocity, and the effect of weight loss on long-term height growth among children and adolescents with obesity.

A prospective study was conducted including patients aged 3 to 18 years who were enrolled in the Swedish Childhood Obesity Treatment Register (BORIS) between 1998 and 2020.

Anthropometric data was collected periodically at clinical visits. Obesity was determined by body mass index (BMI) for age and sex (BMI z score). Individuals were categorized according to degree of obesity, with class I and class II corresponding to a BMI of 30 and 35 kg/m², respectively. Patients with pathological growth disorders were excluded from the study.

Primary study outcomes included the impact of obesity on height and growth velocity, as well as the outcome of obesity treatment on growth velocity. Appropriate height for sex and age was compiled according to the national Swedish reference and used for comparison; growth velocity was similarly compared with a reference population of Swedish children of average maturity.

Obesity treatment outcome, defined as the difference between BMI z score at 1-year follow-up and initial BMI score, was stratified into “poor treatment outcome” (increase in BMI z score), “intermediate treatment outcome” (reduction in BMI z score of 0-0.24 units) and “good treatment outcome” (reduction in BMI z score of ≥0.25 units).

A total of 27,997 children and adolescents were included in the study, with a mean age of 10.2±3.6 years and a mean BMI z score of 2.8 ±0.5 units (55% class I obesity and 45% class II obesity).

Individuals with class II obesity were, on average, taller than those with class I obesity until age 16 for boys and age 15 for girls; however, no difference in height z score was observed thereafter (P >.05). No significant association was found between birth weight for gestational age and height z score.

Boys and girls with class II obesity were found to grow faster relative to their peers with class I obesity until 10 years of age, at which point those with class II obesity were found to have a lower height velocity than individuals with class I obesity.

An inverse relationship was found between the degree of obesity and growth spurt, with a reduced growth spurt found among those with class I obesity and virtually absent among those with class II obesity; these findings were more pronounced among boys than girls.

Compared with the reference population, peak growth velocity among those with obesity and severe obesity occurred at an earlier age; height gain at peak growth velocity was also lower among those with obesity when compared with the reference group.

Of note, individuals aged 3 to 5 years with good treatment outcomes grew more slowly when compared against those with poorer outcomes. Conversely, those aged 10 to 13 years with good treatment outcomes grew faster than those with poorer treatment outcomes.

The lack of data on parental height and age at onset of obesity was cited as a potential study limitation.

The study authors concluded, “Neither modest nor severe obesity is associated with altered final height. Successful obesity treatment does not harm, but rather normalizes, the growth velocity pattern.”

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Children across the world from minority backgrounds and those whose families have low income comprise a higher proportion of PICU admissions for respiratory diseases and are at higher risk for mortality. Researchers at the Emma Children’s Hospital in Amsterdam, Netherlands, therefore sought to determine whether outcomes of children’s respiratory diseases treated at the PICU are adversely influenced by disparities in household income, environment, sex, and ethnicity.

The researchers searched for studies with data on socioeconomic, ethnic, sex, or environmental disparities in patients less than 18 years of age (excluding premature infants) who were admitted to the PICU with a respiratory disease-related primary diagnosis. The search involved the Embase, Web of Science Core Collection, and PubMed databases, from inception through September 2022. Studies involving premature infants were excluded.

The review identified 15 articles (7 on the effect of socioeconomic status; 5 concerning ethnicity; 1 on the effect of sex; 2 concerning environmental factors). The investigators noted all but 1 article showed associations between these factors and adverse PICU outcomes.

The investigators found a significant proportion of PICU admissions (more than 60% in 1 study) were children from deprived neighborhoods, and that this population more frequently received mechanical ventilation and experienced the highest proportion of deaths. Multiple studies indicated that children with severe bronchiolitis coming from households with low-income vs children raised above poverty thresholds experienced longer lengths of stay at the PICU and an increased need for mechanical ventilation.

Overall, the investigators found that living in poverty, being part of an ethnic minority, and living in a deprived area were all negatively correlated with mortality, longer PICU stays, and the need for mechanical ventilation among children in the PICU with acute respiratory diseases.

Study authors noted that children with public health insurance vs those with commercial or HMO insurance as well as those admitted with severe asthma were significantly more likely to receive mechanical ventilation and to have a longer length of stay in the PICU, with longer use of mechanical ventilation.

The investigators found that in the US, Black children vs those of other races/ethnicities admitted to the PICU were significantly more likely to be intubated. No association was found between respiratory failure and sex, age, or obesity. The investigators noted children exposed to environmental tobacco smoke vs those not exposed experienced significantly longer lengths of stay in the PICU.

Review limitations include the high heterogeneity between included studies regarding population, type of disease, and the inequality being addressed; the risk for subjective interpretation of outcome data; and publication bias.

“This review demonstrates that inequalities in children with respiratory diseases at the PICU exist and may have a considerable effect on their morbidity and even mortality when admitted,” review authors concluded. They added that “With increasing child‐poverty numbers and the current recession, we should be looking more closely into these vulnerable patient groups and look for measures on how to prevent these detrimental effects.”

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Sara Y. Tartof, Ph.D., M.P.H., from Kaiser Permanente Southern California in Pasadena, and colleagues estimated the association between receipt of the wild-type BNT162b2 vaccine and medically attended COVID-19 outcomes among children younger than 5 years. Data were included for 24,261 emergency department, urgent care, or outpatient acute respiratory infection encounters (48, 29, and 23 percent, respectively) during the study period.

The researchers found that 10 percent had positive test results for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and 6 percent were vaccinated. Overall, 3.3 and 6.3 percent of cases and controls (without positive test results for SARS-CoV-2), respectively, were vaccinated with two or three doses of BNT162b2. For children who received two or three doses of BNT162b2, the adjusted odds ratio was 0.70, 0.60, and 0.67 for a COVID-19-related emergency department or urgent care encounter, outpatient visits, and either outcome, respectively. The risk for a positive test result for SARS-CoV-2 during emergency department or urgent care and outpatient encounters among those who received two and three doses was 0.56 and 0.88, respectively.

“Updated vaccines will likely be needed to maintain protection against contemporary omicron strains in young children,” the authors write.

Several authors disclosed ties to pharmaceutical companies, including Pfizer, which funded the study.

Abstract/Full Text (subscription or payment may be required)

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The randomized clinical trial (ClinicalTrials.gov Identifier: NCT04619498) evaluated the effectiveness of the PediAppRREST app, an interactive, multimodal, electronic cognitive aid in a tablet app form, for reducing deviations from AHA resuscitation guidelines during the management of simulated pediatric cardiac arrest.

The simulation-based, 3-group parallel trial was conducted between September 2020 and December 2021 at 4 Italian university hospitals, and the analysis occurred from January to June 2022. Participants in pediatrics, emergency medicine, and anesthesiology were randomized to the PediAppRREST app (PediAppRREST intervention group); a paper-based cognitive aid, the AHA Pediatric Advanced Life Support (PALS) pocket reference card (PALS control group); or no cognitive aid (null control group).

The main outcome was the number of deviations from PALS guidelines during management of pediatric cardiac arrest, as measured by a 15-item checklist and error score.

The intention-to-treat analysis included 100 teams (300 residents): 32 teams in the PediAppRREST group, 35 in the PALS group, and 33 in the null control group. The participants and team leaders had a mean age of 29.0 (SD 2.2) years, and 65% were women. Among the participants, 210 were residents in pediatrics, 48 were in anesthesiology, and 42 were in emergency medicine.

The PediAppRREST group had a significantly lower mean number of deviations from guideline recommendations based on error scores (mean [SD] 3.4 [2.0] points) vs the 2 control groups (PALS: mean difference, -3.0 [95% CI, -4.0 to -1.94; P <.001]; null control: mean difference, -2.6 [95% CI, -3.6 to -1.5; P <.001]). No statistically significant difference in error scores occurred between the control groups (mean difference, 0.4; 95% CI, -0.6 to 1.5; P =.59).

In analyses stratified by residency programs, the mean number of deviations from the guidelines was decreased in the PediAppRREST group compared with the control groups in each residency group. The per-protocol analysis had comparable findings to the intention-to-treat analysis.

Team clinical performance according to the Clinical Performance Tool score was significantly increased in the PediAppRREST group (mean [SD], 8.9 [1.6]) vs the PALS group (mean difference, 1.4; 95% CI, 0.4-2.3; P =.002) and null control group (mean difference, 1.1; 95% CI, 0.2-2.1; P =.01).

The main limitation of the study was the inclusion of only residents as participants. In addition, the error score used to assess the primary outcome has not been extensively validated, participants and outcome assessors’ blinding was not possible, and it was a simulation-based rather than real-life study.

“This randomized clinical trial found that the use of the cognitive aid tablet application improved adherence to resuscitation guidelines, thus demonstrating promise for improving patient outcomes, although further studies are necessary to confirm these findings and demonstrate its impact in clinical practice,” wrote the investigators.Disclosure: One of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies, and one of the authors reported having a patent for the PediAppRREST application pending. Please see the original reference for a full list of authors’ disclosures

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Peter C. Jenkins, M.D., from Indiana University School of Medicine in Indianapolis, and colleagues evaluated the association of an emergency department’s pediatric readiness with in-hospital mortality among children of different races and ethnicities with traumatic injuries or acute medical emergencies. The analysis included data from 633,536 children (younger than 18 years) requiring emergency care in 586 emergency departments across 11 states (2012 through 2017).

Researchers found that adjusted mortality of Black children with acute medical emergencies was significantly greater than that of Hispanic children, White children, and children of other races and ethnicities (odds ratio [OR], 1.69; 95 percent confidence interval [CI], 1.59 to 1.79), with findings consistent across all quartile levels of emergency department pediatric readiness. When comparing Black children with traumatic injuries with Hispanic children, White children, and children of other races and ethnicities with traumatic injuries, there were no racial or ethnic disparities in mortality (OR, 1.01; 95 percent CI, 0.89 to 1.15). Children who were treated at hospitals in the highest quartile had significantly lower mortality for both acute medical emergencies (OR, 0.24; 95 percent CI, 0.16 to 0.36) and traumatic injuries (OR, 0.39; 95 percent CI, 0.25 to 0.61) compared with hospitals in the lowest quartile of emergency department pediatric readiness.

“These findings suggest that increased emergency department pediatric readiness may reduce but not eliminate disparities among children with acute medical emergencies, indicating that organizations and initiatives dedicated to increasing emergency department pediatric readiness should consider formal integration of health equity into efforts to improve pediatric emergency care,” the authors write.

Abstract/Full Text

Editorial

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The new clinical practice guideline was developed by the American Dental Association Science & Research Institute (ADASRI), the University of Pittsburgh School of Dental Medicine and the Center for Integrative Global Oral Health at the University of Pennsylvania School of Dental Medicine. The guideline aligns with recommendations from the Food and Drug Administration (FDA), which advise against the use of codeine and tramadol in children less than 12 years of age.

Findings from a systematic review and meta-analysis showed that nonopioid medications, such as ibuprofen and naproxen alone, or with acetaminophen (if pain is not adequately controlled with an NSAID), are recommended for acute dental pain after 1 or more simple and surgical tooth extractions and for the temporary management of toothache when dental care is not immediately available. Dosages provided in the recommendations were based on dosing for prescribed analgesics, which differ from those printed on the over-the-counter (OTC) packaging of these medications.

“This clinical prescribing guideline is a critical step in supporting appropriate treatment of pediatric acute dental pain through the use of acetaminophen and NSAIDs,” said Patrizia Cavazzoni, MD, director of the FDA Center for Drug Evaluation and Research. “Not only will this advice allow for better treatment of this kind of pain, but it will help prevent unnecessary prescribing of medications with abuse potential, including opioids.”

A second guideline for the management of acute dental pain in adolescents and adults is currently in the works.

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Researchers evaluated the characteristics, clinical course, and outcomes of infants less than a year old who were admitted for intensive care at 39 US pediatric hospitals in 27 states between October 17 and December 16, 2022, which was the peak of the RSV season in the US.

Data were obtained from the RSV Pediatric Intensive Care (RSV-PIC) registry, which required admission to an intensive care unit or high acuity unit for at least 24 hours for RSV-related illness, symptom onset of less than 10 days before hospitalization, and evidence of laboratory-confirmed RSV before hospitalization or within 72 hours of admission.

The associations between intubation status and demographic factors, gestational age, and underlying conditions were assessed with mixed-effects multivariable log-binomial regression models to calculate prevalence ratios.

The RSV-PIC registry included 600 infants, of whom 559 (93.2%) were admitted within the first month of the study period. Participants’ median age was 2.6 (interquartile range [IQR], 1.4-6.0) months, 60% were male, 81% were previously healthy, 29% were born prematurely, and about one-quarter were intubated.

Lower respiratory tract infections (LRTIs) were the primary reason for admission (99%), although infants who were intubated had an increased frequency of apnea or bradycardia (13%) and were more frequently younger than 3 months old.

Oxygen support was required in 572 infants (95.3%) at admission, and 143 infants (24%) received invasive mechanical ventilation (median, 6.0 [IQR, 4.0-10] days). Of the infants who were intubated, 101 (70.6%) were younger than 3 months old. High-flow nasal cannula was the highest level of respiratory support for nonintubated infants (40.5%), followed by bilevel positive airway pressure (25.0%) and continuous positive airway pressure (8.7%). The median hospitalization length for surviving infants was 5 (IQR, 4-10) days. Extracorporeal membrane oxygenation was needed in 4 infants, and 2 infants died.

The risk for intubation was highest among infants younger than 3 months old vs those aged 6 to 11 months, those who were born prematurely (<37 weeks), and those who had public rather than private insurance, after adjustment.

Among several limitations, the study population included only the first 15 to 20 consecutive RSV cases at each hospital, and the inclusion of only clinician-ordered, laboratory-confirmed RSV cases may have resulted in missing cases. Also, although most infants were tested for influenza and SARS-CoV-2, only half of infants were tested via a respiratory viral panel. Furthermore, the study period did not include the RSV peak in some states, and the trial was biased toward infants with the most severe RSV infections.

“In this cross-sectional study, most US infants who required intensive care for RSV LRTIs were young, healthy, and born at term,” the study authors concluded, adding that “These findings support the use of new preventative interventions, including long-lasting monoclonal antibodies in all infants and maternal vaccination.”

Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Investigators sought to compare incidence of pacemaker-lead-related complications, hemothorax and venous occlusion, and mortality between epicardial and endocardial pacemakers in children with sinus node dysfunction (SND) or atrioventricular block (AVB).

Pacemaker-lead failure (exit block, fibrosis, insulation break, or fracture leading to malfunction), infection, threshold rise, and battery depletion were the primary outcomes. Mortality and hemothorax and venous occlusion were secondary outcomes.

AVB was defined as any degree of acquired or congenital heart block resulting in delay or interruption of electrical conduction. SND was defined as electrocardiogram findings of sinus arrest for more than 2 seconds, sinoatrial block, tachycardia-bradycardia syndrome, and sinus bradycardia.

The investigators conducted a systematic review and meta-analysis searching the Web of Science, Cochrane Central Register of Controlled Trials, Scopus, PubMed, and OpenGrey databases from inception until June 2022. They included observational cohort or randomized controlled studies in English that compared clinical outcome risks between pediatric patients with SND or AVB who received epicardial pacemaker implantation vs pediatric patients who received endocardial pacemaker implantation.

Eligible studies included more than 75% children with SND or AVB and pacemaker implantation, and more than 90% of study participants were less than 18 years of age. Studies involving only 1 pacemaker type or that did not report event rates, hazard or risk ratios, or 95% confidence intervals were excluded.

Eighteen studies were included in the systematic review and 15 of those studies were included in the meta-analysis. Overall, pediatric patients (N=1348; 40% girls; mean implantation age, 6.8 years) received epicardial or endocardial implantation. Among this patient population, 40.2% had a congenital heart disease diagnosis. The most common indications for pacemaker implantation were congenital AVB (43.2%), acquired AVB (34.2%), and SND (18%).

Epicardial pacemakers were significantly associated with a higher possibility of pacemaker-lead failure (pooled odds ratio, 3.00; 95% CI, 2.05-4.39; I²=0.0%). There were no differences found between pacemaker types for the outcomes of post-implantation infection, possibility for threshold rise, or battery depletion.

Additionally, there was no difference in mortality rates between the epicardial and endocardial groups. Results between the 2 pacemaker types remained consistent through sensitivity analyses.

Included studies were overall of moderate quality with no publication bias.

Limitations of the study include only observational studies were analyzed and there is no comparison between dual and single chamber pacemakers. There is also between-study heterogeneity.

“The findings suggest that EPI [epicardial pacemakers] may be associated with increased PM [pacemaker]-lead failure compared to ENDO [endocardial pacemakers] while threshold rise, infection, battery depletion, and mortality rates did not differ,” investigators wrote. “…more longitudinal multidisciplinary studies are required to validate our results.”

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Noting that there is a lack of clarity on best practices to optimize and sustain desired outcomes for pediatric preventive cardiology programs, Amanda M. Perak, M.D., from Northwestern University in Chicago, and colleagues conducted surveys of pediatric cardiology division directors and pediatric preventive cardiology clinicians across the United States and Canada.

The authors found 47 percent of the respondents reported that their division had a dedicated preventive cardiology program, including in 65 percent of large pediatric cardiology divisions. Most respondents agreed that a dedicated program is a core part of the pediatric cardiology division, including 71 percent of large pediatric cardiology divisions. Most respondents agreed that preventive cardiology programs are valuable for public health, community, and improving clinical outcomes for patients and as an entry point for patients/families into the health system. The biggest challenges for the programs included lack of clinical resources, including physicians, dieticians, and clinical support; lack of interest or dedication from health care teams; financial sustainability; and lack of patient adherence. To improve the practice of pediatric preventive cardiology, the authors said updated guidelines, a registry study for outcomes, studies of novel care models in primary prevention, and advanced fellowship training programs are needed.

“Pediatric preventive cardiology services are in high demand but are underresourced and operating with limited guidance,” the authors write. “We urge policymakers, payers, hospitals, heart centers, professional societies, foundations, and funders to match investments into pediatric preventive cardiology to the gravity and urgency of our youths’ high burden of cardiovascular disease risk.”

Several authors disclosed ties to the biopharmaceutical industry.

Abstract/Full Text (subscription or payment may be required)

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Each year in the United States (US), roughly 1% of infants are born with congenital heart disease (CHD).¹ Additionally, research from the Centers for Disease Control and Prevention showed that nearly 1 million US children aged 0 to 17 years (1.3% of the pediatric population) had a current heart condition in 2016, based on responses to parent surveys. Compared with healthy children, those with a heart condition had 1 or more special health care needs, such as prescription medications, speech or occupational therapy, or mental or behavioral health counseling.²

Providing optimal medical care for these patients requires close collaboration with their parents, and having discussions regarding the diagnosis, prognosis, and treatment of a child with cardiovascular disease can be challenging for clinicians. Among the potential communication barriers that may affect these conversations, findings have demonstrated that approximately one-third of US adults have low health literacy, and more than one-third of pediatric medical residents and faculty have received no training in health literacy.³

Despite the important influence of parental knowledge on the quality of care and quality of life of children with CHD, researchers have observed significant gaps in parental knowledge about CHD in this population.⁴ One study found that only 16.4% of parents of a child with CHD received education about how to care for the child at home following discharge from the hospital.⁵

For recommendations regarding effective strategies in educating parents of children with complex cardiovascular diagnoses such as CHD, we interviewed the following experts:

• Madeleine Townsend, MD, pediatric cardiologist at Cleveland Clinic Children’s Hospital in Cleveland, Ohio

• David Brown, MD, cardiologist at Boston Children’s Hospital and professor of medicine at Harvard Medical School in Boston, Massachusetts

• Daphne T. Hsu, MD, chief of cardiology at Children’s Hospital at Montefiore and professor of pediatric cardiology at Albert Einstein College of Medicine in Bronx, New York
• Amanda J. Shillingford, MD, FACC, physician at the Cardiac Center at Children’s Hospital of Philadelphia and medical director of the Fetal Heart Program Annex at CHOP’s Bryn Mawr Specialty Care Center in Pennsylvania

When speaking with the family of children with complex diagnoses, how do you taper your information dissemination as it relates to diagnosis, treatment, and prognosis without overwhelming them? Is it preferable to share all the information at once or incrementally over multiple visits?

Dr Townsend: Explaining new and life-changing diagnoses to families is inevitably a very challenging conversation to open. The complexity of explaining new terminology, various treatment options, and particularly the range of outcomes to shocked parents who are grieving their “healthy” child can be very overwhelming. Medical providers understandably feel they are trying to convey too much information at once, while also battling the necessity of ensuring families are able to make informed decisions on next steps in care.

Open and clear communication in these settings often involves opening the conversation with information on the diagnosis and the next steps that need to be considered, with a plan to allow this information to settle and then come back for another meeting to evaluate parental understanding and continue to expand on the conversation with additional details. The timeline of follow-up meetings is often dependent on the need to make quick decisions on next steps in care—for example, with prenatal diagnoses where termination may be an option.

Providers can help families in these situations by acknowledging emotions, clearly communicating specific information with the help of nonverbal teaching tools such as diagrams or models, providing well-vetted online resources such as websites and parental support group information for further education at home, and being aware of how the provider is presenting the information.⁶

Parental perception of provider empathy and compassion has been found to be inversely linked with the likelihood of seeking a second opinion.⁷ Allowing adequate time for detailed conversation and remembering the importance of nonverbal communication, such as body posture and position, can ensure that families feel heard and valued.

Using a multidisciplinary team approach can also be helpful, with the incorporation of additional supports such as palliative care or psychology, as these providers may have different ways of communicating with families that can help clarify the information, as well as expose any misunderstandings that families do not bring to the pediatric cardiologist’s attention.

The “teach back” technique can be helpful, with open questions to families such as “What have you heard me say?” and “Tell me how you will explain this to your other family members.” Making sure families know there will be additional opportunities to speak again and reminding them to write down questions before the next meeting can also help to ease parental anxiety about the need to understand everything immediately.

Dr Brown: I find the approach that works best for families of children with complex diagnoses is to consider the first discussion the beginning of a conversation that will continue and evolve over time. That first conversation is important, as you are creating a framework upon which you and the family will build understanding over time.

It is easy to overload families with too much information and detail in that first meeting, particularly for those hearing about complex diagnoses for the first time—sometimes all they remember from that conversation is that their child has a serious problem. I usually try to have simple goals for that first conversation—what is the diagnosis, what are the treatments that might be required, and what is the expected longer-term outcome and quality of life for their child.

Just like any conversation, families will give cues—both verbal and nonverbal—about how they are processing the discussion, and those cues can help you determine if you are giving them too much information, not enough, or about right. Leaving time and space for comments and questions is really important, and if they are not asking clarifying questions, one can ask them questions to probe understanding or find out which questions or concerns they might have that you haven’t addressed.

With the next conversation, you can fill out the framework that began with the first conversation. I will often start by asking what they understand about their child’s diagnosis, as this can help you understand where to pick up the conversation. I usually plan on discussing these same things again, regardless—diagnosis, treatments, outcomes—with perhaps more detail about the treatment options and anticipated outcomes, again taking cues from the family about where they are in their understanding of these issues.

Dr Hsu: I view the first conversation as a way to set the stage for the ongoing conversations that will take place while I am caring for the child. I start by giving a “big picture” of the problem, focusing on what the clinical issues are that are impacting the child and what treatments are available to help improve them. Discussion of treatments includes outlining the risks and benefits, and most importantly, which particular treatment should make the child better and why. The idea of getting better or worse is the essence of prognosis, so that is a natural part of the conversation.

One of the rewards of our field is that the cardiac team establishes a relationship with a patient and family that may be lifelong, so it is important to let the patient and family know that the first conversation is one of many and at each time they should be comfortable asking questions and getting answers. 

Dr Shillingford: This can definitely be a challenge, as there are multiple factors that should be considered when counseling parents about a new diagnosis of complex CHD. As a fetal and outpatient pediatric cardiologist, I deliver information to parents under variable circumstances. Parents present with a broad range of educational and mental health foundations, religious beliefs, and psychosocial supports, all of which impact how they will receive and process the information. 

There is emerging research revealing high rates of mental health disturbances – including post-traumatic stress, anxiety, and depression—in parents of children with complex CHD, which has lasting effects on coping and parenting.⁸ However, there are also multiple studies engaging parent feedback specifically related to what is helpful and what is not helpful during counseling. What I have learned from these studies is that parents want a balanced delivery—they request honesty and realism, but they also want to have hope for their child’s future.

Fetal cardiology and prenatal diagnosis of CHD are my particular areas of interest.   Depending on the timing of diagnosis during the pregnancy, parents may be considering their options regarding continuation of the pregnancy and delivery location, which may require geographical relocation. For me personally, I adjust my counseling content based on the severity of the disease, what I have learned about the parents from questionnaires or records available in the EMR and real time feedback based on my interaction with them.

I begin the session by asking the family what they have been told about the fetal cardiology appointment or the need for a fetal echo. I do believe that it is important to be honest and provide realistic expectations to families, especially if parents are making decisions about pregnancy continuation. If the pregnancy is beyond termination limits, and definitely if the parent is significantly emotionally distressed, I will abbreviate the counseling sessions and utilize multiple visits.

Sometimes, parents will be upfront and state, “I can’t hear all of this now, just tell me if there is a treatment,” or, “I have researched this diagnosis and here is the information I know. Please tell me CHOP’s experience, services, and outcomes.”  For the CHOP Fetal Heart Program, we have incredible psychosocial supports for families, with nursing, social work, and psychology as part of the “counseling team.”

A few principles I use for counseling the more complex forms of CHD when I walk in the room:

• Acknowledge that a heart defect was identified and that a treatment strategy is available.
• Describe “normal” cardiac physiology – many people really have no idea about CHD, and it is difficult to explain why certain interventions are needed without understanding why the child’s heart is different.
• Discuss a plan for pregnancy monitoring – in most CHD cases, the baby can still have a “normal” delivery, and most newborns appear quite normal early after birth.
• Review the general perinatal plan for the postnatal assessment, monitoring, and planning, and reassure families that in most cases, they will be able to hold their baby after birth and before surgery, will likely be able to feed a bit, and that breastfeeding will be an option.
• Discuss the general surgical plan and postoperative care, as well as the need for life long follow up.
• I tend not to get into details regarding the specific [numerical] risk of morbidity and mortality for each procedure, but rather emphasize that pediatric cardiac centers are developed so that the specialized providers are all familiar with their child’s cardiac condition and will do everything possible to reduce these risks.
• I include a discussion about potential risks balanced with the reality that the vast majority of children who have undergone newborn heart surgery can progress through “normal” childhood and adult activities.
• I invite questions throughout the counseling session, and I emphasize the fact that they have received a lot of information that may be very difficult to process and that they will have the opportunity to hear the information again.
• I always provide contact information for me or my team to be available for follow-up counseling after the appointment.
• I ask parents—sometimes only mothers—about their supports. Some families will look to peer supports or internet resources. I do try to guide them to educational content on reputable websites, and I will provide information for parent CHD groups which some parents find helpful—although with the caveat that it is important to understand that not every internet CHD story can be extrapolated to their case.
• It is also important to alleviate parental guilt by simply stating, “We do not know what causes CHD. This is not your fault. We are here to support you through this process.”

In the outpatient world, I still follow many of the principles above. In this situation, the children may be older or the severity of CHD may be less. In this scenario, parents may not be expecting to find out their child has a cardiac problem requiring surgery or medication. I will still balance having realistic expectations. However, I may spread out the discussions over several visits. I often try to call families a few days after such an office visit in order to check in and give them an opportunity to ask questions. When applicable, I contact the primary physician to update them on a new diagnosis.

What resources do you use in educating families with low health literacy, and how do you gauge their level of comfort or understanding? What are some resources or strategies you would recommend for your peers who work in settings with high rates of low health literacy?

Dr Townsend: Lower health literacy has been linked to decreased understanding by families of their child’s medical diagnosis.³ Identifying families with lower health literacy is an important first step when meeting new families, as extra care should be taken when communicating information in order to improve family understanding, which can then lead to increased adherence and improved outcomes.⁹

Utilizing diagrams and models and other nonwritten communication tools can be a useful strategy to improve understanding of a diagnosis and proposed treatment options. It is also important to ensure information is written at the appropriate literacy level and in the family’s preferred language, which can mean reaching out nationally to other pediatric cardiology providers who may have access to written information in different languages or utilizing a translator service within the hospital system or online.

The same techniques discussed above are helpful to gauge understanding, especially the teach back system, as well as ensuring that follow-up meetings are scheduled to evaluate initial understanding and address any questions or concerns that arise.

Dr Brown: When it comes to complex medical diagnoses, many families will find it challenging to understand, especially the first time they hear about them. For those with low health literacy, images or physical models are often very helpful when used appropriately. For example, with a particular heart defect, you can use a graphic of a normal heart to point out normal structures, and then modify the drawing to show where the problem is with their child’s heart.

Three-dimensional heart models are also very helpful in that families can hold them and turn them around in space to get a better understanding of the problem. There are also excellent online resources available now, including 3-D reconstructions from imaging studies—for example, from MRI or CT—of children with similar diagnoses that can help families arrive at a better understanding of the problem.

Dr Hsu: I assume that virtually all patients and families have a low health literacy when it comes to heart diseases in children, as they are extremely rare and families are unlikely to have had prior personal experiences with the issues that arise in pediatric heart diseases. For imparting knowledge about the child’s specific heart problem, it is difficult to refer patients to web- or paper-based materials, as they are often too general to be applicable and can confuse or cause increased anxiety, so I prefer that there is a give and take between the cardiac team and the family about specific decisions.

That said, the impact of a serious illness on the child and family cannot be underestimated, and it is important to talk about ways families cope with this type of stress. I let patients and families know that there are many excellent organizations where they can hear other families’ experiences and get general information about diseases and treatment, and I make sure they always feel free to bring that knowledge back to the team so that any questions can be answered. In the field of heart transplant, matching a patient and family with a family that has been through the process can be invaluable because it makes them feel less alone.

The importance of having a good understanding of the patient and family’s cultures, support system, social supports, and challenges cannot be overstated. The impact of a serious illness on all aspects of a family’s life has the potential to impact the child’s disease, and identifying how best to help a family and patient be the best partners in a patient’s care is essential. For patients who are not native English speakers, the use of translators is crucial to making sure that the finer details of care are addressed and that patients can ask more complex questions comfortably. 

Asking the patient to tell you in their own words what they understood about the problem and treatments that were discussed at the visit is a great way to gauge their understanding of what is planned and why, and this can let the team know if there are gaps that can be addressed.

Dr Shillingford: I provide some sort of written documentation of the diagnosis, which includes a picture. Although not a perfect strategy, I begin any counseling discussion by asking parents if they have a medical background and what they understand about the heart already—this is more relevant for fetal CHD, which is often referred to us from another provider who diagnosed or suspects a cardiac defect. I write down the medical diagnosis as well as the more basic description—for example, “Ventricular Septal Defect = ‘Hole’ between the bottom chambers of the heart.”

For CHD specifically, there are numerous online resources which can be accessed. I use the American Heart Association and the CDC descriptions of CHD, and there are also Spanish versions of these resources. Children’s Heart Foundation is an advocacy and fundraising group with excellent CHD resources, including a book called It’s My Heart, which covers many CHD topics in plain language since it was vetted by parents. Mended Little Hearts is another organization geared towards parental support and advocacy, and they also have online resources.

How can a physician best gauge a child’s potential readiness to be involved in discussions regarding management of their illness?

Dr Townsend: With the growing population of children with CHD surviving and thriving into adulthood, there is an increasing need to support successful transition of care from the pediatric to adult setting. Multiple tools exist to gauge an adolescent patient’s readiness for transition, including the Transition Readiness Assessment Questionnaire, the MyHeart scale, the General Self-Efficacy scale, and the Children’s Uncertainty in Illness Scale.¹⁰

Starting transition discussions early, at the onset of adolescence, with age-appropriate education on the patient’s diagnosis and long-term care needs, as well as helping guide families toward giving increasing autonomy to their children, can help to provide gradual readiness for transition of care as well as increased involvement in medical decision making.

Dr Brown: Some basics are helpful and important in assessing readiness to be involved, such as the age of the child and whether there are any barriers to communication such as spoken language or developmental delay. Families can often help you understand if a child has certain fears or concerns that should be approached carefully. The older the child, the more agency and voice they should have in these discussions.

Just as adults do in these conversations, children will give verbal and nonverbal cues about what they are understanding and whether they would like to be involved in illness management discussions. An invitation to be part of the conversation is often the best approach, and can be as simple as asking, “What questions do you have about this?” or “What do you think about what we have been talking about?”

Dr Hsu: Speaking directly to the child during the visit is an important way to make them feel included. As soon as the child can answer questions about level of activity, play, and interests at school, this is a great way to establish a relationship with the child. Letting the child ask questions is a great way to gauge understanding and address the important issues. I also try to speak directly to the child at the end of the visit to offer reassurance to the child about their heart disease, as children may not understand all the nuances of the conversations that take place during the visit. 

Dr Shillingford: This is also a challenge because parents have different ways that they involve their child in decision making. Generally, pre-adolescence is the time when I start to speak more directly to the child about the findings from their visit and make sure to allow the child time to ask questions. I ask them if they are interested in looking at an echocardiogram picture for example, but if the child does not ask many questions and the parent is not actively including them in the discussion, then I will defer detailed discussions with the child until the late teens years when I talk about the future need to transition to an adult provider. CHOP has a Transition to Adulthood program which we can refer to, but the “transition” process may take several years before all of the patient’s care is fully with an adult provider.

It can be physically and emotionally challenging for cardiologists working with complex cases, especially when there are language and health literacy barriers. How do you balance your work and mental health to prevent burnout and compassion fatigue?

Dr Townsend: Caring for children with CHD and their families can be challenging, particularly for patients who spend extended periods of time in the hospital. We live in in the day-to-day ups and downs of complex medical care with patients and their families, and we experience heartbreak when things go poorly—and jubilation when kids get better and can go home.

It is important to purposefully detach from the work environment, spending time away with friends and family as well as focusing on one’s own health with regular exercise and sleep. Often those times away are enough of a mental break to allow clinicians to return to the hospital energized. It is truly the personal connections we make with our patients daily that provide joy and satisfaction that the hard work we do is worthwhile, and if the opportunity arises to see them outside the hospital—for example, at a heart camp—that can help confirm the benefit of the time and care we put into helping children achieve their best lives. 

Dr Brown: Often this type of communication is not done solo but as part of a team, which can be incredibly helpful. Taking the time to reflect with others on challenging cases or difficult conversations, and simply sharing that experience with others, is a very powerful way to lessen the mental and emotional burden. Most physicians are now paying more attention to self-care and making sure there is time to do things that bring relaxation and joy outside of work and allow relationships to be nurtured that can keep fatigue and burnout at bay.

Dr Hsu: Being able to help families and patients at a critical time in their lives is a great privilege and carries with it great rewards because of the appreciation that comes along with the work. Having a family light up when you enter a room because you are a familiar face and they know that you are doing everything you can to help is an experience that is unlike any other. We often speak of purpose in life, and purpose is something caring for children with heart disease has in large quantities.

Personally, I love the fact that I get to be a part of so many different lives, and that part of my job is learning about different cultures, social structures, hobbies, and the hopes and dreams of my patients. Sad things happen in what we do, and in those times, I try to remember what one of my teachers used to say: “We didn’t give them the disease, we are just trying to help.” Working with the patients and families also makes me have a greater appreciation for the good things I have in my life. 

Dr Shillingford: I wish I had an answer for this question. I currently have teenagers at home, and I have missed many games and school events because I am with a patient or parent who requires more attention. It is a constant struggle to balance these demands. I have at times tried to set boundaries or limit patient loads in order to “refuel,” but there is some degree of guilt which comes with that as well. I have wonderful colleagues who I love working with, however I also have activities and friends who have no affiliation with my work which allows me to “escape” when I leave work.

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Investigators aimed to explore the association between gestational ages and obstructive airway disease (COPD and/or asthma) through assessment of a population of adults aged 18 to 50 years. Additionally, the researchers explored whether this association differed among individuals born preterm and diagnosed with bronchopulmonary dysplasia (BPD) or those who were born small for gestational age (SGA).

The researchers conducted a population-based register study using medical birth registers that included all live births in Norway from 1967 to 1999 (n=1,669,528) of which 5.0% were preterm and in Finland from 1987 to 1998 (n=706,717) of which 4.8% were preterm. Specialized health care registers in Norway (2008-2017) and in Finland (2005-2016) were used to obtain data concerning care episodes of COPD or asthma.

Ultrasonography was not used in Norway to confirm duration of gestation until December 1998 and was not used in Finland until the late 1980s or early 1990s. Prior to that, clinical examination or data on the last menstrual period was used to estimate duration of gestation. Gestational age was defined as extremely preterm (23-27 weeks), very preterm (28-31 weeks), moderately preterm (32-33 weeks), late preterm (34-36 weeks), early term (37-38 weeks), full term (39-41 weeks, reference) and post-term (≥42 weeks).

For individuals born extremely or very preterm, investigators found that odds of any obstructive airway disease in early adulthood were 2- to 3-fold compared with individuals born full term. These odds were 1.1- to 1.5-fold among individuals born moderately or late preterm, or early term compared with individuals born full term.  

Investigators noted that for those 30 to 50 years of age with COPD, the odds ratio was 7.44 (95% CI, 3.49-15.85) for those born extremely preterm; 3.18 (95% CI, 2.23-4.54) for those born very preterm; 2.32 (95% CI, 1.72-3.12) for those born moderately preterm. Study authors found subgroup associations similar among people 18 to 29 and 30 to 50 years of age and among people in the Norwegian and Finnish databases.

For asthma, the risk was higher in all groups born preterm except for those born in Finland moderately preterm.

Odds of any obstructive airway disease in adulthood were further increased for those born extremely or very preterm if they experienced BPD in infancy.

Individuals born early term and extremely, very, and late preterm in Norway and those born early term and very preterm in Finland compared with those born full term, had higher odds for obstructive airway disease if they were born SGA.

Study limitations include unverifiable diagnoses and pregnancy dating based on last menstrual period.

“Preterm birth should be recognized as a risk factor for obstructive airway diseases in adulthood, and full medical history for people presenting with respiratory symptoms should include key perinatal data such as birth weight, gestational age and key pregnancy conditions,” investigators concluded. Investigators stated that among very or extremely preterm-born individuals, “the excess risks are clinically significant and call for particular diagnostic vigilance,” when these individuals present with respiratory symptoms.

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Study authors sought to evaluate the safety of nirsevimab compared with palivizumab for RSV protection in children with CHD and CLD who had received a second seasonal dosing of nirsevimab. Researchers also estimated the efficacy of the second seasonal dose of nirsevimab, using pharmacokinetic extrapolation to determine whether children reached nirsevimab serum levels adequate to protect them against RSV exposure. Researchers considered 80% of children achieving the protective serum level to be indicative of successful efficacy.

Investigators for the current study built upon the results of the phase 2/3 MEDLEY trial (ClinicalTrials.gov Identifier: NCT03959488), which evaluated the safety and efficacy of nirsevimab for RSV protection in preterm infants with CHD and CLD during their first RSV season. The 310 children enrolled in that trial were all eligible to receive palivizumab according to local or national guidelines and were randomized to receive nirsevimab (50 mg for weight less than 5kg; 100 mg for weight of 5kg or more), palivizumab (15 mg per kilogram of weight), and/or placebo.

The current second-season analysis, conducted from July 28, 2020, to April 30, 2022, included 262 children approximately 15 to 16 months old. Of those, 252 children completed at least 150 days of follow-up after the second season. Participants in the current analysis were divided into 3 treatment groups:

• Those who received nirsevimab prior to the first RSV season who then received nirsevimab 200 mg followed by 4 once-monthly doses of placebo in the second season (N/N, n=180).
• Those who received palivizumab prior to the first RSV season and who then received nirsevimab 200 mg followed by 4 once-monthly doses of placebo in the second season (P/N, n=40).
• Those who received palivizumab prior to the first RSV season and then received palivizumab intramuscularly for 5 once-monthly doses (P/P, n=42).

Investigators then assessed adverse events (AEs), anti-drug antibodies, and nirsevimab serum concentrations for children in the 3 groups through day 360 following the first dose they received for season 2. The safety analysis also assessed AEs through 30 days post first treatment dose, thus allowing investigators to compare AEs resulting from 1 dose of nirsevimab vs palivizumab.

The investigators found that the overall incidence of 1 or more serious AEs was higher among P/N and N/N groups, compared with the P/P group, respectively (10.0% vs 9.4% vs 0.0%). The researchers noted that these events were primarily due to infections or underlying comorbidities and no safety-related trends or concerns were identified. Additionally, the incidence of adverse events of grade 3 or greater severity was higher among the P/N and N/N group, compared with the P/P group, respectively (10.0% vs 7.8% vs 2.4%).

The incidence of anti-drug antibodies (ADAs) was minimal in the N/N treatment group; ADAs were detected in only 1 participant prior to the first RSV season and none after.

With respect to efficacy, the investigators found that 98% of the P/N and N/N treatment groups achieved target serum concentrations associated with efficacy.

Study limitations include small sample sizes in the P/P and P/N treatment groups and the timing of the trial, which took place during the COVID-19 pandemic and may thus have influenced results.

“In children with congenital heart disease and/or chronic lung disease, 200 mg nirsevimab administered before their second RSV season had a similar safety profile to that of palivizumab and achieved serum exposures at levels associated with efficacy in healthy infants,” the study authors concluded.

Disclosures: This study was supported by AstraZeneca and Sanofi. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

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Investigators sought to determine if infants with ASD express a distinct cardiac morphology and function within the first month of birth. They conducted a case-control study using echocardiographic data from a cohort of 716 unselected neonates with ASD included in the Copenhagen Baby Heart Study (CBHS; ClinicalTrials.gov Identifier: NCT02753348), a population-based, multicenter study (N=27,595). CBHS inclusion was offered to all expectant parents from April 2016 through October 2018 in the Capital Region of Denmark. All but 5 neonates received transthoracic echocardiography within 60 days after birth.

Neonates from the CBHS study without ASD (control patients) were matched for sex (52% girls) and age in a 1:1 ratio with neonates with ASD at the time of echocardiographic examination (mean age 11 days). Additionally, neonates with ASD vs control patients were well-matched for median gestational age at birth (280 days vs 281 days), mean body surface area (Haycock formula, 0.23 vs 0.23), mean birth weight (3474 g vs 3488 g), and mean birth length (51.3 cm vs 51.6 cm).

A majority of neonates with ASD (90%) had left-to-right shunting while 10% had both left-to-right and right-to-left shunting. There were no neonates with only right-to-left shunting.

The investigators found that neonates with ASD vs the control patients had larger right ventricular (RV) dimensions (RV outflow tract diameter, 13.6 mm vs 12.4 mm; RV basal dimension end-diastole, 14.9 mm vs 13.8 mm; RV longitudinal dimension end-diastole, 27.7 mm vs 26.7 mm; all P <.001).

Neonates with ASD vs control patients had larger tricuspid annular plane systolic excursion (10.2 mm vs 9.6 mm) and larger atrial volumes (right atrial end-systolic volume, 2.9 mL vs 2.1 mL; left atrial end-systolic volume, 2.0 mL vs 1.8 mL; all P <.001). There was a slightly larger main pulmonary artery diameter in patients with ASD but it was not statistically significant.

There was no between-group differences in left ventricular dimensions and function.

Study limitations include echocardiographic interobserver variability and inclusion of neonates with asymptomatic and smaller ASD defects than typical in clinical settings.

“…ASDs were associated with altered cardiac dimensions already in the neonatal period, with larger right ventricular dimensions and larger atrial volumes at echocardiography within the first 30 days after birth,” the investigators wrote. “These findings indicate that the morphological cardiac changes typical for ASDs are found very early in life after only a few days of left-to-right shunting.”

Disclosure: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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The cross-sectional study aimed to assess the quality of resuscitation in adult and pediatric shockable and nonshockable OHCA via use of in situ high fidelity simulation in emergency medical service (EMS) professionals and evaluate the effects of cognitive load and knowledge.

The study was performed at 7 urban EMS agencies in the Portland, Oregon, metropolitan area between September 2020 and August 2021. Each EMS crew completed 4 simulation scenarios: an adult woman with shockable arrest and ventricular fibrillation on arrival; an adult woman with pulseless electrical activity; a school-aged child with ventricular fibrillation; and an infant with pulseless electrical activity. At EMS arrival all patients were pulseless.

The rates of errors were compared between the adult and pediatric scenarios. Defect-free care included correct cardiopulmonary resuscitation (CPR) depth, rate, compression-to-ventilation ratio, timely bag-mask ventilation (BVM), and timely defibrillation if applicable.

A total of 215 EMS clinicians from 39 crews participated (93% men; mean [SD] age, 38.7 [0.6] years). The EMS members had a mean (SD) of 10 (4.1) years of EMS experience.

In the pediatric scenarios, delays were observed in time to CPR, time to BVM, vascular access, and time to initial dose of epinephrine vs the adult scenarios. None of the pediatric shockable scenarios and 5 pediatric nonshockable scenarios (12.8%) were defect free, and 27 adult nonshockable scenarios (69.2%) were defect free.

In a comparison of the mean (SD) National Aeronautics and Space Administration task load index (NASA-TLX) scores of the paramedic team leader for each scenario, the highest cognitive load occurred in the pediatric nonshockable scenario (48.4 [13.8]), followed by the pediatric shockable scenario (43.6 [15.2]), adult shockable scenario (41.1 [13.7]), and adult nonshockable scenario (39.3 [13.3]).

The pediatric scenarios had significantly increased overall mean (SD) NASA-TLX scores compared with the adult scenarios with use of 1-way analysis of variance (ANOVA; pediatric, 45.4 [14.4]; adult, 41.2 [13.5]; P =.01). The mental demand subscale of the mean (SD) NASA-TLX was greater in the pediatric scenarios vs the adult scenarios (pediatric, 59.1 [20.7]; adult, 51.4 [21.1]; P =.01).

The difference in overall Clinical Teamwork Scale (CTS) in the 4 scenarios was not statistically significant per ANOVA (P =.062) and was relatively small in size. The overall knowledge test scores were not significantly different in the adult and pediatric knowledge assessments.

The multivariable model showed that the posterior probability of defect-free care was associated with scenario type. The probabilities of defect-free care were 67% (95% CI, 50%-84%), 29% (95% CI, 15%-44%), 17% (95% CI, 5%-28%), and 3% (95% CI, −3% to 8%) in the adult nonshockable, adult shockable, pediatric nonshockable, and pediatric shockable scenarios, respectively.

In further analysis, mental demand also was associated with scenario type. The pediatric nonshockable scenario was associated with a 10.6-point increase in mental demand (95% CI, 6.3-15.0 points). An increase in Pediatric Advanced Life Support knowledge assessment score was associated with a 5% increased probability of defect-free care (95% CI, 0.6%-10.3%). CTS, NASA-TLX score, years of experience, and Advanced Cardiac Life Support knowledge evaluation score were not associated with defect-free care.

The researchers noted that all events were simulated and cannot be correlated with clinical outcomes, and the results may be biased in favor of better overall performance than what would occur in a clinical setting. Also, the study was conducted in a single geographic area with relatively high OHCA survival and may not be generalizable to other EMS systems.

“In this study of simulated pediatric and adult OHCA, pediatric cases consistently had delays in initiating critical interventions and lower-quality care, while paramedics also experienced significantly higher cognitive load in the pediatric scenarios,” wrote the study authors. “Increased cognitive load may contribute to challenges in pediatric resuscitation.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Nirsevimab is a long-acting anti-RSV monoclonal antibody that is administered as a single dose timed to the RSV season. The approval was based on data from the nirsevimab clinical development program, which included a phase 2b trial (ClinicalTrials.gov Identifier: NCT02878330), the phase 3 MELODY trial (ClinicalTrials.gov Identifier: NCT03979313), and the phase 2/3 MEDLEY trial (ClinicalTrials.gov Identifier: NCT03959488).

In the phase 2b trial, infants who were born during or entering their first RSV season were randomly assigned to receive a single dose of Beyfortus (n=969) or placebo (n=484). Findings showed that treatment with Beyfortus significantly reduced the incidence of medically-attended lower respiratory tract disease caused by RSV by 70.1% (95% CI, 52.3-81.2; P <.001) compared with placebo. There were 25 cases reported in the Beyfortus group and 46 cases reported in the placebo group.

The MELODY trial compared a single intramuscular (IM) injection of nirsevimab to placebo in 1490 healthy infants who were born at a gestational age of at least 35 weeks. Findings showed that treatment with nirsevimab was associated with a statistically significant reduction in the incidence of medically-attended RSV-associated lower respiratory tract infection (LRTI) and a lower incidence of hospitalization for RSV-associated LRTI compared with placebo. 

In the randomized, double-blind MEDLEY trial, the safety and tolerability of nirsevimab was compared with palivizumab in approximately 925 infants with congenital heart disease, chronic lung disease, and/or prematurity before entering their first RSV season. Findings showed that nirsevimab demonstrated a similar safety and tolerability profile compared with palivizumab. 

“Today’s approval marks an unprecedented moment for protecting infant health in the US, following an RSV season that took a record toll on infants, their families, and the US healthcare system,” said Thomas Triomphe, Executive Vice President, Vaccines, Sanofi. “Beyfortus is the only monoclonal antibody approved for passive immunization to provide safe and effective protection for all infants during their first RSV season.” 

The most common adverse reactions reported with Beyfortus were rash and injection site reactions. Beyfortus carries a risk for serious hypersensitivity reactions, including anaphylaxis. Health care providers should exercise caution when administering to infants and children with clinically significant bleeding disorders.

Beyfortus is supplied as a 50mg/0.5mL and 100mg/mL prefilled syringe. The product is expected to be available for the upcoming 2023-2024 RSV season.

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Study authors aimed to characterize EoE presentations among pediatric patients of varying weight classes.

Investigators conducted an observational study of children less than 19 years of age newly diagnosed with EoE at an academic medical center in the US from January 2015 to December 2018. The study included 341 patients (31% girls; 81% White, 12% Black, 2% Asian). Based on Centers for Disease Control and Prevention definitions, 19% had obesity (≥95^th percentile), 14% overweight (85^th-94^th percentile), 63% normal weight (5^th-84^th percentile), and 5% underweight (<5^th percentile). Symptoms at presentation included vomiting, nausea, food refusal, gastroesophageal reflux disease, chest pain, choking, and abdominal pain.

Investigators found children with obese body mass index (BMI) were more likely to complain of abdominal pain than children in the other weight groups (obese 40% vs 18% underweight, 21% normal weight, 19% overweight). Moreover, children in the group with obesity were more likely to be diagnosed at an older age (mean [SD] age in years: obese 11.6 [4.1] vs underweight 7.9 [6.1], normal weight 8.8 [4.9], overweight 9.3 [5.3]; P =.0005). No other presenting symptoms showed significant differences among weight groups.

Children with obesity and overweight vs those with underweight and normal weight were less likely to be tested for inhalant allergies (obese, 8%; overweight, 12%; underweight, 29%; normal weight, 23%) and food allergies (obese, 13%; overweight, 26%; underweight, 41%; normal weight, 30%).

Investigators found no significant between-group differences on endoscopy concerning the presence of linear furrows, tracheal rings, erythema, white specks, or edema/loss of vascularity. They noted no significant differences between children in the obese/overweight groups and children in the normal weight group concerning eosinophil counts in esophageal biopsies.

Investigators noted no significant differences concerning sex, race, asthma, atopic dermatitis, allergic rhinitis, or type of insurance relative to EoE diagnosis and weight group.

Study limitations include family and parental recall bias and the possible inclusion of children who had proton-pump-inhibitor-responsive esophageal eosinophilia rather than EoE.

“[C]hildren with obese and overweight status had a chief complaint of abdominal pain more commonly, and were diagnosed at later ages, than children of normal and underweight status. Clinical suspicion must remain high for EoE in children of all BMI subclasses as they may present differently,” investigators concluded.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Investigators conducted a systematic review and meta-analysis to evaluate RSV diagnostic testing modalities for their sensitivity in detecting pediatric RSV and to assess the value of testing multiple specimens.

The systematic review identified 157 primary studies on RSV detection in children and young adults (aged <18 years) with at least 2 types of specimens or diagnostic tests in the same population. The researchers searched Embase, MEDLINE (via PubMed), and Web of Science for relevant articles published from January 1, 2000, to December 27, 2021, as well as nonindexed sources and RSV research networks.

RSV detection rates were compared for combined testing (with multiple specimens or diagnostic tests) and test-specific (reference) conditions and were presented as detection rate ratios (DRR).

Of the 157 studies included for meta-analysis, 85 (54.1%) involved nasopharyngeal aspirates (NPAs) and 53 studies (33.8%) used nasopharyngeal swab (NPS). Multiplex and singleplex RT-PCR were used in 86 (54.8%) and 50 (31.8%) studies, respectively, and rapid antigen detection tests (RADT) were used in 56 studies (35.7%).

Testing of multiple respiratory specimens with any method was associated with a small increase in RSV detection (all nonstatistically significant trends) for the specimen types that were analyzed. With use of RT-PCR on NPA/NPS or paired specimens, additional testing of oropharyngeal swabs (OPS) to NPS/NPA increased RSV detection by 5% (DRR 1.05; 95% CI, 0.96-1.14). Additional testing of nasal swabs (NS) to NPA/NPS increased detection by 8% (DRR, 1.08; 95% CI, 0.94-1.25), and the addition of NPS to NPA increased RSV detection by 1% (DRR, 1.01; 95% CI, 0.94-1.08). The addition of paired serology testing to RT-PCR on NPS was associated with a 10% increased RSV detection rate in 1 report (DRR, 1.10; 95% CI, 0.95-1.27).

Detection ratios according to age group for added paired serology were as follows: 0 to 6 months: DRR 1.02 (95% CI, 0.76-1.36); 7 months to 2 years: DRR, 1.12 (95% CI, 0.94-1.33); 3 to 5 years: DRR, 1.04 (95% CI, 0.73-1.48); and 6 to 17 years: DRR, 1.29 (95% CI, 0.65-2.54).

In 21 studies with 28 comparisons of RADT as index tests compared with RT-PCR, the pooled sensitivity was 75% (95% CI, 69%-80%) and ranged from 26% to 100%. The pooled sensitivity of direct fluorescent antibody vs RT-PCR was 87% (95% CI, 78-93%), with a range of 72% to 96%, with comparable findings occurring with singleplex and multiplex RT-PCR references. Viral culture had a pooled sensitivity of 76% vs RT-PCR (95% CI, 71%-81%), with a range of 75% to 100% and a pooled specificity of 100% (95% CI, 99%-100%).

With respect to study limitations, 60% of studies had an overall high or unclear risk of bias, and most of the studies did not include sufficient demographic data or information about specimen storage and handling. Also, the comparison of diagnostic test performance used RT-PCR as a common reference.

“RT-PCR was the most sensitive pediatric RSV diagnostic test,” the investigators concluded. “Adding multiple specimens did not substantially increase RSV detection, but even small proportional increases could result in meaningful changes in burden estimates. The synergistic effect of adding multiple specimens should be evaluated,” said the study authors.

Disclosure: This work was supported by Pfizer Inc. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

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Investigators in China aimed to characterize long-term and short-term effects of cesarean section on childhood asthma and wheezing. To accomplish this, the researchers conducted a study of children in China and synthesized their findings with a meta-analysis of existing literature on this topic.

For their original study, the researchers analyzed a cohort of 6501 infants seen at 30 days of age (baseline) at 15 vaccination clinics in Jinan, Shandong, China, from January 2018 to December 2019. Of that cohort, 2961 (45.5%) children were born via cesarean section. (Notably, this percentage is far above the global average rate of 18.6%, said the study authors). Children were followed-up at 2 years of age for respiratory diseases. A logistic regression model was used to estimate the effect of cesarean section on asthma and wheezing.

The researchers noted a 1.3% cumulative incidence of asthma and wheezing (1.35% in those with a cesarean section delivery; 1.24% in those born via vaginal delivery). The odds of cesarean section delivery affecting the asthma and wheezing status of children under 2 years of age was not significant (adjusted odds ratio [aOR], 1.14; 95% CI, 0.73-1.78; P =.78). Notably, boys demonstrated a significantly higher incidence of asthma and wheezing than girls (1.6% vs 0.9%; P =.015).  

For meta-analysis purposes, investigators conducted a search of PubMed, Web of Science, and Medline databases from inception to May 2022 for observational studies involving participants (up to 18 years of age) born via vaginal delivery or cesarean section that reported on outcomes of asthma or persistent wheezing. The researchers identified 56 studies (more than 5.3 million participants) that showed incidence of asthma and wheezing, varied by age group (3.6%, 0-2 years; 7.8%, 2-4 years; 3.7%, 4-12 years; 0.55%, 12-18 years).

The meta-analysis, which included both the 56 studies identified for analysis and the investigators’ original research, showed cesarean section was a risk factor for asthma and wheezing for children under 2 years of age (OR, 1.15; 95% CI, 1.05-1.25; I²=46.82%).

Among children over 2 years of age, the meta-analysis found that cesarean section increased the risk for asthma and wheezing with substantial heterogeneity (OR, 1.17; 95% CI, 1.11-1.24; I²=79.38%). Investigators noted a significant overall effect of cesarean section on childhood asthma and wheezing with considerable heterogeneity (OR, 1.19; 95% CI, 1.14-1.24; I²=84.12%). Both emergency and elective cesarean section was associated with increased risk of asthma and wheezing in children, with the risk higher for emergency cesareans.

The odds ratio of cesarean section affecting asthma and wheezing in univariate analysis was 1.09 (95% CI, 0.71-1.67). Study authors noted cesarean section trended to increase risk of asthma and wheezing without statistical significance in the multivariate logistic regression model (aOR, 1.17; 95% CI, 0.75-1.80). Somewhat stronger associations (lacking statistical significance) were noted among children who were female vs male when stratified by child sex.

Study limitations include the use of a preponderance of studies conducted in Europe for the meta-analysis.

“Cesarean section was found to have a tendency to increase the risk of asthma and wheezing before 2 years of age, and when our results were pooled with previous literature, cesarean section was found to increase the risk of asthma and wheezing before the age of 2,” investigators concluded. They added, “Meta-analysis found that cesarean section has a long-term effect on asthma and wheezing, which persisted up to the age of 18 years.”

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Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor. Its approval for pediatric use was based on efficacy and safety data from the phase 3 DINAMO trial (ClinicalTrials.gov Identifier: NCT03429543), which included 157 patients 10 to 17 years of age with inadequately controlled T2DM. Patients were randomly assigned 1:1:1 to receive empagliflozin 10mg, linagliptin 5mg, or placebo orally once daily for 26 weeks. At week 12, empagliflozin-treated patients who did not achieve an HbA1c of less than 7% were re-randomized to remain on 10mg or increased to 25mg. 

Results showed that empagliflozin (pooled 10mg and 25mg doses) in addition to other baseline therapies (diet, exercise, metformin and/or insulin) reduced HbA1c by 0.8% at week 26 compared with placebo (95% CI, -1.5, -0.2; P =.0116). Treatment with linagliptin did not achieve statistical significance in HbA1c reduction when compared with placebo.

The overall safety profile of empagliflozin was generally consistent with previous findings in adults with T2DM. In pediatric patients aged 10 years and older, the risk of hypoglycemia was higher with empagliflozin regardless of insulin use.

“Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” said Michelle Carey, MD, MPH, associate director for therapeutic review for the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes.”

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To support the development of an RSV surveillance system, investigators conducted a systematic literature review and meta-analysis to estimate the incidence of RSV-related disease incidence, hospitalization, in-hospital mortality, and overall mortality in children 5 years of age and younger.

A search of relevant peer-reviewed articles published from January 1, 2010, to June 2, 2022, in multiple English- and Chinese-language databases yielded 44 studies for meta-analysis; of these, 34 were considered high quality and 10 were moderate quality. The pooled studies involved 149,321,171 participants, with sample sizes ranging from 1153 to 30,417,106 patients.

Of the included studies, 15 reported RSV-related disease incidence (107,527 participants), 25 reported RSV-related hospitalization rates (62,691,095 participants), 9 reported RSV-related in-hospital mortality rates (55,149,680 participants), and 5 reported RSV-related overall mortality (31,317,106 participants).

The pooled incidence, hospitalization rate, in-hospital mortality rate, and overall mortality rate in children 5 years of age and younger were 9.0 (95% CI, 7.0-11.0), 1.7 (95% CI, 1.3-2.1), 0.5 (95% CI, 0.4-0.5), and 0.05 (95% CI, 0.04-0.06), respectively, per 100 children per year, according to the random-effects model.

In a subanalysis of different age groups, the pooled estimated RSV-related disease incidence in 2- to 5-year-old children (3.0 per 100 children per year; 95% CI, 2.0-5.0) was significantly lower compared with that in 0- to 1-year-old children (9.0 per 100 children per year; 95% CI, 6.0-12.0) and 0- to 2-year-old children (9.0 per 100 children per year; 95% CI, 7.0-11.0). A similar trend occurred in RSV-related hospitalization rate, in-hospital mortality rate, and overall mortality rate.

RSV-related disease incidence was greater in high-income countries vs low- and middle-income countries combined (15.0 per 100 children per year; 95% CI, 8.0-23.0 vs 7.0 per 100 children per year, 95% CI, 5.0-9.0), per World Bank classification. In high-income countries, RSV-related overall mortality was lower compared with low- and middle-income countries combined (0.02 per 100 children per year; 95% CI, 0.01-0.02 vs 0.9 per 100 children per year; 95% CI, 0.6-1.2).

The pooled estimated incidence of RSV-related disease in active surveillance studies was significantly greater than that reported in passive surveillance studies (12.0 per 100 children per year; 95% CI, 8.0-17.0 vs 3.0 per 100 children per year; 95% CI, 0-6.0).

Study limitations involve the inclusion of only articles published in English and Chinese; considerable heterogeneity among included studies; and the inclusion of only studies relating to outpatients and community-based surveillance.

“A standardized and unified RSV surveillance system is required. Case definition and surveillance types should be fully considered for surveillance of different age groups,” noted the study authors, who added that children aged 2 and younger should be a high priority target population of surveillance efforts.

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The device uses pulse oximetry technology to track an infant’s heart rate and oxygen saturation level. When readings fall outside the ranges set by a clinician, BabySat provides an alert to the caregiver.

“Our mission is to provide caregivers with the right information at the right time to make informed decisions about their baby’s health,” said Kurt Workman, CEO and co-founder. “Today, parents whose babies need additional monitoring are sent home with traditional solutions that can be restrictive and more cumbersome for parents. BabySat pushes forward the modernization of hospital-grade technology for at-home use, and underscores our commitment to transforming baby care solutions.”

BabySat is expected to be available later this year.

The post FDA Clears BabySat, an At-Home Pulse Oximetry Sock Device for Infants appeared first on The Cardiology Advisor.

Adolescent hypertension has been associated with adverse renal and cardiovascular outcomes. Among adults who have had a stroke, hypertension is the most common modifiable risk factor.

To evaluate whether adolescent hypertension is also related with long-term stroke risk, investigators from Tel Aviv University sourced data from the Israeli Defense Forces and linked Israeli National Stroke Registry. Between 1985 and 2013, adolescents (N=1,900,387) received a medical evaluation prior to their compulsory military service. Stroke risk was compared between individuals who had an average blood pressure (BP) of greater than 140/90 mm Hg with those who did not.

The adolescents with (n=5221) and without (n=1,895,166) hypertension had a mean age of 17.6 (SD, 0.6) and 17.3 (SD, 0.5) years (P <.001), 91.8% and 57.6% were boys or men (P <.001), 42.2% and 78.9% had a normal BMI (P <.001), 46.6% and 70.2% had unimpaired health (P <.001), and 5.7% and 1.3% had diabetes (P <.001), respectively.

The average systolic BP was 143.3 and 116.2 mm Hg and diastolic BP was 82.5 and 71.4 mm Hg among the hypertensive and control cohorts (both P <.001), respectively.

A total of 1474 first-documented stroke events occurred during a cumulative follow-up of 11,386,187 person-years. The median age at stroke was 43.2 years and 84% of events were ischemic.

In the fully adjusted model, risk for stroke was elevated among individuals with adolescent hypertension compared with the general population (adjusted hazard ratio [aHR], 2.1; 95% CI, 1.3-3.5).

Stratified by age at stroke, the rates of stroke were similar between the groups with and without adolescent hypertension at younger than 40 years of age. However, at ages 40 to 42 (rate ratio [RR], 7.7; 95% CI, 2.9-21.1), 43 to 45 (RR, 4.9; 95% CI, 1.9-13.2), 46 to 48 (RR, 4.3; 95% CI, 1.8-10.4), and 49 to 52 (RR, 4.7; 95% CI, 1.7-12.8) years, rates of stroke were elevated among those who had hypertension during adolescence.

In subgroups, adolescent hypertension remained associated with all-cause stroke risk among patients with unimpaired health (HR, 3.0; 95% CI, 1.7-5.7; P <.001), who were overweight or obese (HR, 2.7; 95% CI, 1.6-4.7; P <.001), and without diabetes (HR, 2.1; 95% CI, 1.1-4.0; P =.02) compared with control patients. Similar trends were observed for ischemic stroke risk.

This study may have been limited by the small number of stroke cases among the adolescent hypertension cohort (n=18).

“…hypertension, even in otherwise healthy adolescents, was associated with overall and specifically ischemic stroke in young adulthood,” the study authors wrote. “These findings suggest a potential clinical benefit of hypertension screening among adolescents.”

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Researchers conducted a study between January and March 2020 to examine perceptions and attitudes among adolescents regarding COVID-19 vaccination and vaccine mandate and passport policies. Data for this study were collected through surveys and interviews designed by youth researchers. Eligible participants were students from 2 low-income neighborhoods in Montreal, Canada. The survey was designed to capture sociodemographic-related predictors of COVID-19 vaccination status.

The study population comprised 315 participants (age range, 14-17 years), of whom 82 were not fully vaccinated. Among all participants, 56% were women, 70% were aged between 15 and 16 years, approximately 90% were non-White, and one-third were born outside of Canada. The majority of participants were fully vaccinated (~75%), whereas 8% were partially vaccinated and 18% were unvaccinated.

Among unvaccinated participants, the most commonly reported reasons for refusing the COVID-19 vaccine included safety concerns (24%), perceived lack of effectiveness (16%), and low risk for severe illness (14%).

Participants who were fully vs not fully vaccinated were significantly more likely to view vaccination as a measure to protect the health of the community and report that the COVID-19 vaccine is safe (13% vs 44%; P <.001) and effective (33% vs 58%; P <.001). Vaccinated participants also reported higher rates of family and friends who were vaccinated (83% vs 62%), greater support for vaccine passports (47% vs 38%), and greater trust in national health authorities (29% vs 52%), health care workers (13% vs 30 %), and scientific experts (17% vs 32%).

Further analysis showed that vaccinated vs unvaccinated participants did not significantly differ in regard to the belief that only those at risk for severe illness require vaccination and that daily life constraints contribute to vaccination decisions. In addition, participants in both groups reported low trust in information about COVID-19 vaccines provided by social media, celebrities, and school guidelines or teachers.

Participants who were unvaccinated commonly described vaccine mandate and passport policies as “unfair” and cited their right to bodily autonomy in making medical decisions.

“Some adolescents remarked on the absurdity of deciding to get vaccinated to be able to eat in restaurants and play sports, rather than to protect their health,” the researchers noted.

Limitations of this study include the relatively small sample size.

According to the researchers, “Strategies that increase the trustworthiness of institutions and foster genuine partnership with underserved youth may improve vaccine confidence and help ensure an effective, pro-equity recovery from COVID-19.”

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Investigators compared demographic and clinical characteristics and outcomes of pediatric patients hospitalized with RSV, influenza, or COVID-19 at Children’s Hospital Colorado in Aurora, Colorado, during the 2021-2022 season. The retrospective cohort study used public health surveillance data from the Colorado Department of Public Health and Environment (CDPHE). Participants were children (aged <18 years) with RSV, influenza, or SARS-CoV-2 infection admitted from October 1, 2021, to April 30, 2022, when SARS-CoV-2 delta and omicron variants were also circulating.

The primary outcome was intensive care unit (ICU) admission. Multivariable log-binomial regression modeling was used to assess the association regarding pathogen type and ICU admission, pneumonia and bronchiolitis diagnosis, hospital length of stay, and highest level of respiratory support received.

A total of 837 hospitalized children were included in the analysis: 487 with RSV, 303 with COVID-19, and 47 with influenza. The children had an overall median age of 1.5 years (interquartile range, 0.4, 4.1), and 45% were female. The patients with RSV were younger (median age, 1 year) vs those with SARS-CoV-2 (2.7 years) and influenza (6.1 years). A higher proportion of children who had influenza were Hispanic/Latinx (43.1%) vs those with RSV (31.2%) and SARS-CoV-2 (35.3%; P =.0143).

Of the hospitalized children with influenza and known vaccination status, 28 (68%) were either partially or fully vaccinated. Of those with SARS-CoV-2 infection, 36 (32.4%) were partially vaccinated or had their primary series. A higher proportion of asymptomatic children had SARS-CoV-2 (7.2%) compared with influenza (2.0%) and RSV (0.2%; P <.0001).

The median hospital length of stay was greater in children with RSV (4 days vs 3 days for SARS-CoV-2 and influenza; P =.0009). ICU admission rates and hospital length of stay were not significantly different, although children with SARS-CoV-2 more frequently received pressor support (8.2%) and invasive mechanical ventilation for their highest level of respiratory support (7.2%) compared with the children who had RSV and influenza (P < .001 for both).

In multivariable log-binomial regression analyses, using COVID-19 as the reference group, ICU admission risk was greater in children who had influenza (relative risk [RR] 1.97; 95% CI, 1.22-3.19). Children with RSV had a higher risk of pneumonia (RR 2.32; 95% CI, 1.54-3.52) and bronchiolitis (RR 2.93; 95% CI, 2.28-3.78). A hospital stay of more than 4 days (RR 1.40; 95% CI, 1.12-1.76) and greater oxygen support (RR 2.01; 95% CI, 1.54-2.63) also were more likely in children with RSV.

Study limitations include the use of retrospective data involving only hospitalized children; the single-center design; the inability to provide population-based estimates of disease burden; and lack of evaluation of other viral pathogens, such as rhinovirus.

“In a season with pathogen cocirculation of RSV, influenza, and SARS-CoV-2, hospitalizations were primarily RSV-associated, predominantly due to respiratory illnesses, with requirements for higher levels of oxygen and noninvasive respiratory support compared with the needs of children with SARS-CoV-2 and influenza,” stated the investigators. “Given the likely seasonal cocirculation of these pathogens, ongoing comparison of their clinical characteristics and evaluation of their overall disease burden is essential to optimize treatment and prevention strategies.”

Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

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The clinical presentation and outcomes of COVID-19 have been shown to be milder among children than adults; however, data on the effect of COVID-19 specifically on pediatric autoimmune rheumatic diseases are limited.

In a single-center prospective study, researchers aimed to evaluate the rate of relapse among children with autoimmune rheumatic diseases after COVID-19 infection and vaccination.

Between March 2020 and April 2022, data on demographics, disease activity, clinical presentation, and serology were collected from patients in Sweden with autoimmune rheumatic diseases with COVID-19 infection and vaccination.

Relapse was defined as worsening of disease in 8 weeks after infection or vaccination.

A total of 115 patients with pediatric autoimmune rheumatic diseases were included in the study, of whom 92 had COVID-19 infection, 47 received vaccination, and 24 had both. All vaccinated patients received 2 doses of the Pfizer vaccine 3.7 (SD, 1.4) weeks apart. The most common diagnosis in both groups was juvenile idiopathic arthritis.

Results showed that the clinical presentation of COVID-19 infection was asymptomatic in 14 (14%) patients, mild in 69 (67%) and moderate in 19 (18%). One patient was hospitalized due to COVID-19-related infection and was unvaccinated.

Of 103 infections, 10 (10%) resulted in relapse of disease. The majority of relapses were of mild or moderate severity, with 1 case of severe relapse requiring hospitalization. The difference in relapse rate was not statistically significant (P =.76) between those who had COVID-19 infection and those who received vaccination.

Study limitations included the age differences (range, 2-23 years) among eligible participants and the study’s single-center design.

Overall, the study authors concluded, “There is a trend towards a higher relapse rate in [pediatric autoimmune rheumatic diseases] after infection compared to vaccination and connection between the severity of COVID-19 and vaccination status is plausible.”

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Homozygous familial hypercholesterolemia is a rare disease that presents as elevated low-density lipoprotein cholesterol (LDL-C) from birth coupled with accelerated development of atherosclerotic cardiovascular disease (ASCVD). At the time of the previous HOFH statement by the EAS in 2014, there were few therapeutic options available for HOFH.

The 2023 statement provided updated diagnostic criteria, screening recommendations, treatment algorithms, and guidance about family planning as well as new insights into the genetics of the disease.

The updated criteria for HOFH diagnosis are an untreated LDL-C level of greater than 13 mmol/L or a level of greater than 8 mmol/L in patients receiving standard therapy. Additional criteria include cutaneous or tendon xanthomas before the age of 10 years or having both parents with LDL-C levels consistent with heterozygous familial hypercholesteremia. Physicians should rule out other conditions that could be responsible for elevated LDL-C.

Even if they do not meet the LDL-C criteria, patients suspected of having HOFH should receive genetic evaluation, as there can be LDL-C variability in this genetically complex disease. The most common affected pathogenic variants that have been associated with HOFH include a loss-of-function variant in low-density lipoprotein receptor (LDLR), a receptor-binding defective variant in apolipoprotein B (APOB), and a gain-of-function variant in proprotein convertase subtilisin/kexin type 9 (PCSK9). However, patients with HOFH may be carriers of other variants. As such, the EAS recommended for patients with suspected HOFH to receive targeted next-generation sequencing to both confirm the diagnosis and to guide appropriate treatment.

Patients with HOFH should be referred to a specialist for treatment and reverse cascade screening. These patients likely require multidisciplinary care involving pediatricians and cardiologists.

At diagnosis, patients should be started on high-intensity statins and ezetimibe. PCSK9-directed therapy should be added within 8 weeks. After patients have received 1 or 2 doses of PCSK9-targeted therapy, this therapy may be discontinued if the patient has not had a greater than 15% reduction in LDL-C.

The recommended LDL-C treatment target for children is less than 3 mmol/L and for adults is less than 1.8 or 1.4 mmol/L for patients without or with ASCVD risk factors, respectively. For patients who do not meet treatment goals, lomitapide and/or angiopoietin-like protein 3 (ANGPTL3)-directed therapy with or without lipoprotein apheresis should be considered.

 “HOFH is still underdiagnosed and/or identified too late and remains undertreated despite its severe adverse impact on cardiovascular health,” the study authors wrote. “The last decade has seen much progress, particularly with new highly efficacious LDL-C-lowering therapies which offer the prospect of LDL-C goal attainment, leading to improved survival and quality of life.”

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

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The prospective, cross-sectional study evaluated use of the Healthy Eating Assessment Tool (HEAT) in meeting dietary fat and cholesterol restriction cut points of CHILD-2 and its association with adiposity and lipid variable markers. The study enrolled patients aged 2 to 18 years from a pediatric dyslipidemia clinic over 2 years.

The researchers assessed the association between individual HEAT scores and HEAT score categories (poor, 0-4.5; fair, 5-6.5; good, 7-8.5; and excellent, 9-10; analysis of variance) and factors such as nutritional analysis findings of 7-day food records, body mass index (BMI) z-score, waist-to-height ratio, and lipid variables.

Participants who had the highest HEAT scores (good, 43%; excellent, 64%) met the CHILD-2 cut point of less than 25% total fat calories (P =.03), with a nonsignificant trend (P =.08) for saturated fat to less than 8% of total daily calories (excellent, 64%).

Having a lower HEAT score was associated with an increased BMI z-score (r = -0.31, P <.01) and waist-to-height ratio (r = -0.31, P <.01).

No association was observed between HEAT score and any lipid variable after adjustment for age, sex, amount of moderate to vigorous physical activity, hours of screen time, use of lipid-lowering medications, BMI z-score, and waist-to-height ratio.

“HEAT score associations with meeting CHILD-2 fat targets were modest, with more consistent associations with markers of adiposity, and no independent association with lipid levels,” wrote the study authors. “While fat-restricted diets are safe, they are not particularly effective for treatment of dyslipidemia or for weight management alone. The HEAT may be a more useful and simplified way of assessing and tracking broader dietary goals in clinical practice.”

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Researchers aimed to assess the safety and efficacy of evinacumab in young pediatric patients with HOFH. During Part B of the study, among the intent-to-treat (ITT) population, mean percent change in LDL-C to week 24 from baseline was the primary efficacy endpoint.

The researchers conducted an open-label, multicenter, 3-part study (ClinicalTrials.gov Identifier: NCT04233918) that included 6 patients in Part A (mean age, 8.8±1.7 years; 67% girls), 14 patients in Part B (mean age, 9.1±1.9 years; 57% girls), and all 20 of these patients in an ongoing Part C. Inclusion criteria included the patients being aged 5 to 11 years, with LDL-C greater than 130 mg/dL while being treated with lipid-lowering therapy.

Part A (16-week Phase 1b, open-label, single dose intravenous (IV) evinacumab 15 mg/kg) aimed to evaluate pharmacokinetics, pharmacodynamics, and safety of evinacumab. Part B (24-week Phase 3, open-label, evinacumab 15 mg/kg IV every 4 weeks [Q4W]) aimed to evaluate the efficacy and safety of evinacumab in 14 patients who did not participate in Part A. Part C (48-week Phase 3 on-going, open-label extension with 24-week follow-up, evinacumab 15 mg/kg IV Q4W) aimed to evaluate long-term efficacy and safety of evinacumab and included all 20 patients from Parts A and B.

There was a mean maximum LDL-C reduction of 41.6% (SD, 18.3%) after 8 weeks among all 6 patients in Part A. Of patients in Part B, 78.6% experienced at least a 50% reduction in LDL-C after 24 weeks. At week 24, among the 14 patients in Part B, there was a mean percent change from baseline of -48.3%±10.4%. Additional mean percent changes from baseline to week 24 occured (total cholesterol, -49.1%±8.1%; non-high-density lipoprotein cholesterol, -48.9%±9.8%; apolipoprotein B, -41.3%±9.0%).

There was a -43.0%±12.8% mean percent change in LDL-C for patients with a defective/negative low-density lipoprotein receptor (LDLR) variant (LDLR activity >15%) and -67.7%±6.5% for patients with a negative/negative LDLR variant (LDLR activity ≤15%).

The researchers noted that 10 of the 14 patients in Part B experienced treatment-emergent adverse events (TEAEs). There were 2 of these patients in whom TEAEs were treatment-related (abdominal pain and nausea). Additionally, patients experienced oropharyngeal pain (n=3), diarrhea (n=2), vomiting (n=2), headache (n=2), and nasopharyngitis (n=2). There was 1 patient who experienced a serious TEAE (tonsilitis), not considered treatment-related. There were 3 patients who experienced at least 1 severe TEAE. They reported no deaths or treatment discontinuations due to TEAEs.

A limitation of this study is the small sample size.

“In very-young pediatric patients with HOFH (aged 5–11 years) and inadequately controlled LDL-C despite optimized lipid-lowering therapy (including apheresis and lomitapide), evinacumab rapidly and durably lowered LDL-C, with considerable reductions of 48% by week 24,” the researchers wrote. “Evinacumab was generally well tolerated, and the safety profile remained consistent with that observed in adult and adolescent patients, with no new safety signals observed.”

Disclosure: This research was supported by Regeneron Pharmaceuticals, Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Children with severe bacterial infections often have underlying comorbidities, anatomical abnormalities, and risk factors associated with compromised immune function. As there remains a paucity of data guiding patient management in this area, a study was designed to assess the role of routine immunologic testing among otherwise healthy children recovering from severe bacterial infection.

Investigators at the University Children’s Hospital in Zurich, Switzerland conducted this retrospective, single-center, cohort study. Patients (N=360) with bacterial pleuropneumonia, meningitis, and/or sepsis were observed between 2013 and 2020. Immunologic data were collected during follow-up visits, including neutrophil count and function, complement activity, and total immunoglobulin (Ig) concentrations. Antibody testing, pocked erythrocyte assessments, and lymphocyte phenotyping via flow cytometry were also performed.

Among patients included in the analysis, the median age was 3.37 (range, 0-15.9) years, 57% were boys, 57% had pleuropneumonia, and 42% were infected with unknown pathogens. Overall, follow-up data were available for 265 patients (74%).

For patients infected with Neisseria meningitidis (n=16) and Haemophilus influenzae (n=14), meningococcal serogroup B (50%) and type b (Hib; 50%) were the most commonly detected of all group isolates. For patients infected with S pneumoniae (n=87), PCV13 serotypes were the most commonly detected (31%).

During the follow-up period, 92% of children completed immunologic testing, of whom 78% had no abnormalities detected. There were 37 patients with immune abnormalities of unclear clinical relevance, including those with mild humoral abnormalities (11%) or unclear abnormalities in the innate immune system (4%).

Stratified by infection, patients with sepsis, septic meningitis, and those younger than 1 year were more likely to have abnormalities suggestive of impaired immune function.

Of note, autoimmune neutropenia following S pneumoniae sepsis was detected in 1 patient.

Among 3 (1%) patients who died, postmortem laboratory findings identified low IgG and/or IgM concentrations or decreases in all lymphocyte subpopulations. However, these findings were not considered significant due to unclear clinical relevance.

Limitations of this study include the retrospective design and the lack of standardized immunologic testing.

According to the investigators, “The recognition of even minor immunological abnormalities can be important, and we there suggest routinely performing inmmunological investigations in children after recovery…”

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The Hospitalized RSV Monoclonal Antibody Prevention (HARMONIE) phase 3b trial (ClinicalTrials.gov Identifier: NCT05437510) is a large interventional clinical trial to determine the safety and efficacy of a single intramuscular dose of nirsevimab. Real-world data were collected from more than 8000 infants across 250 treatment sites in Germany and the United Kingdom during the 2022 to 2023 RSV season.

Compared with infants who received no RSV intervention, researchers observed that 1 dose of nirsevimab led to reductions in several measures, as follows:

• Hospitalizations due to RSV-related LRTI (83.21%; 95% CI, 67.77-92.04; P <.001);
• Incident hospitalizations due to severe RSV-related LRTI (75.71%; 95% CI, 32.85-92.91; P <.001); and
• Incident all-cause hospitalizations due to LRTI (58.04%; 95% CI, 39.69-71.19; P <.001).

Owing to these findings, “[T]he overall burden on healthcare systems could be reduced significantly if all infants receive nirsevimab,” the researchers noted.

The post Nirsevimab Safe for Infants With RSV, Significantly Reduces Hospitalization Incidence appeared first on The Cardiology Advisor.

During childhood, T1D is among the most common inherited chronic disease. Younger patients with T1D are also at an increased risk of psychiatric disorders, such as depression, anxiety, and neurodevelopmental disorders. Several studies have found that those with T1D have an increased propensity for school absenteeism and lower examination scores, which can lead to adult unemployment. Researchers aimed to examine the educational outcomes of those with T1D with psychiatric disorders and those without. Patients were assessed on whether a comorbidity is associated with an increased risk of adverse educational outcomes.

A total of 2,454,862 adolescents aged a median of 9.5 years, were included in the study, with 13,294 diagnosed with T1D. The researchers used the Swediabkids database and the National Diabetes Register to identify patients with T1D, and the Clinical Database for Child and Adolescent Mental Health Services and Habilitation Register in Stockholm County was used to obtain psychiatric disorder diagnoses. Included psychiatric disorders consisted primarily of neurodevelopmental disorders (autism, ADHD, learning disorders, communication disorders, depression, anxiety, eating disorders, bipolar disorder, psychotic disorder and substance abuse).

The primary endpoint was to examine educational outcomes of those with T1D with and without psychiatric disorders. Secondary endpoints consisted of associations amongst different types of psychiatric disorders on educational outcomes. Educational milestones that were evaluated consisted of achievement of compulsory school performance and being eligible for upper secondary school, as well as starting and finishing university.

Multivariate adjustment models found that adolescents with T1D and no psychiatric disorders were comparable to those without T1D and no psychiatric disorders in achieving educational milestones (OR, 1.09; 95% CI, 0.93-1.28). Of the adolescents included, 7.6% had a diagnosis of at least 1 psychiatric disorder before the age of 16 and a higher likelihood of having asthma, epilepsy, or autoimmune disorders. The researchers noted adolescents diagnosed with T1D and psychiatric disorders had lower odds of achieving educational milestones, including completing their required education (odds ratio [OR], 0.17; 95% CI, 0.13-0.21), being eligible for secondary school (OR, 0.25; 95% CI, 0.21-0.30), and finishing upper secondary school (OR, 0.19; 95% CI, 0.14-0.26). Additionally, diagnosed adolescents had difficulty starting (OR, 0.36; 95% CI, 0.29-0.46) or finishing (OR, 0.30; 95% CI, 0.20-0.47) a university.

Of all psychiatric disorders, those with neurodevelopmental disorders were the most disadvantaged. Adolescents with T1D and a psychiatric disorder had a lower odd of completing compulsory school (OR, 0.09; 95% CI, 0.06-0.13), being eligible for secondary school (OR, 0.19; 95% CI, 0.14-0.25) and finishing (OR, 0.26; 95% CI, 0.20-0.34) upper secondary school, and starting university (OR, 0.26; 95% CI, 0.14-0.47). Overall, adolescents with T1D may benefit from identifying psychiatric disorders early to lower the effect on educational performance.

Study limitations include the inability to capture up to date changes in pediatric treatment of diabetes, as well as screen for all psychiatric disorders, and the possible educational gap when compared to other countries.

The researchers concluded “in support of the current diabetes guidelines, clinical vigilance of psychiatric disorders in pediatric patients with diabetes is warranted.” They added, “Early detection and timely intervention can minimize the adverse effects of psychiatric disorders not only on diabetes outcomes but also on educational attainment, which can further influence other life course outcomes.”

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Researchers aimed to analyze hemoglobin A_1c (HbA_1c) trajectories stratified by ethnicity and insurance in an effort to evaluate the effect social and payer-related restrictions on health outcomes.

The researchers enrolled participants into a clinical research pilot program, termed Teamwork, Targets, Technology and Tight Control (4T), which initiated CGM using the Dexcom G6 system (Dexcom) within 1 month of diagnosis. Patients aged younger than 18 years with T1DM were enrolled between July 25, 2018, and June 15, 2020. Participants also received weekly insulin dose change recommendations by certified diabetes care and education specialists, sent via MyChart electronic medical system.

Participant race was self reported, and insurance type (public vs private) was determined by electronic medical record.

The primary outcome was change in HbA_1c from 4 months to 12 months postdiagnosis. Secondary outcomes included participants who met target HbA_1c levels of less than 7.5% or 7.0%, according to the American Diabetes Association guidelines and data analysis, respectively.

A historical cohort of 272 patients was compared to the Pilot-4T cohort. The median age of the historical cohort was 9.7 years, mean HbA_1c at diagnosis was 10.7%, and there was 56.2% CGM use within 30 days or less of diagnosis.

A total of 135 patients (52.6% boys and 47.4% girls) were evaluated in the Pilot-4T cohort study. Of these patients, 77.0% had private insurance and 23.0% had public insurance. Self reported ethnicity included 21.5% Hispanic patients and 68.1% non-Hispanic patients. Average HbA_1c at diagnosis was 12.2%, with a median CGM initiation of 7 days (range 5-11 days).

Overall, compared with the historical cohort, Pilot-4T participants had improvements in HbA_1c, regardless of ethnicity or insurance.

For Hispanic patients, HbA_1c was lower at 6, 9, and 12 months in the Pilot-4T cohort compared with the historical cohort (estimated differences, -0.26% [95% CI, -1.05% to 0.43%], -0.60% [95% CI, -1.46% to 0.21%], and -0.15% [95% CI, -1.48% to 0.80%], respectively).

Patients with public insurance in the Pilot-4T cohort followed similar trends at 6, 9, and 12 months (estimated difference, -0.52% [95% CI, -1.22% to 0.15%], -0.38% [95% CI, -1.26% to 0.33%], and -0.57% [95% CI, -2.08% to 0.74%]). Patients with private insurance also had similar results at 6, 9, and 12 months (estimated difference, -0.34% [95% CI, -0.67% to 0.03%], -0.57% [95% CI, -0.85% to -0.26%], and -0.43% [95% CI, -0.85% to 0.01%]).

Lower HbA_1c at diagnosis and higher HbA_1c at 6, 9, and 12 months postdiagnosis were observed for Hispanic patients compared with non-Hispanic patients (estimated difference, 0.28% [95% CI, -0.46% to 0.86%], 0.63% [95% CI, 0.02% to 1.20%], and 1.39% [95% CI, 0.37% to 1.96%]) and for patients that had public vs private insurance (estimated difference, 0.39% [95% CI, -0.23% to 0.99%], 0.95% [95% CI, 0.28% to 1.45%], and 1.16% [95% CI, -0.09% to 2.13%]).

A greater proportion of patients in the Pilot-4T cohort achieved a HbA_1c target of less than 7.0% at 12 months postdiagnosis more frequently (Hispanic vs non-Hispanic ethnicity: 47.0% vs 54.0%; public vs private insurance: 47.0% vs 57.0%) compared with historical subgroups (Hispanic vs non-Hispanic ethnicity: 24.0% vs 30.0%; public vs private insurance: 19.0% vs 30.0%).

Limitations of the study include the sample size and lack of individuals who identify as non-Hispanic Black, which limits generalizability.

“The findings of this cohort study suggest that universal access to CGM at diabetes diagnosis was associated with an improvement in HbA_1c for all participants independent of ethnicity and insurance status but not with elimination of disparities in our Pilot-4T cohort,” the study authors wrote. “Payers, clinicians, and technology developers should strive to address these gaps in diabetes technology access and to better identify and address drivers of disparities in HbA_1c outcomes.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Congenital thrombotic thrombocytopenic purpura (cTTP) results from a deficiency in ADAMTS13, a von Willebrand factor (VWF) cleaving protease. This leads to an accumulation of ultra-large VWF multimers in the blood and uncontrolled platelet aggregation and adhesion. TAK-755 is a recombinant ADAMTS13 protein designed to replace the missing or deficient ADAMTS13 enzyme.

The BLA is supported by data from a randomized, controlled phase 3 study (ClinicalTrials.gov Identifier: NCT03393975). Patients were randomly assigned to receive either TAK-755 or the current standard of care (SOC) therapy (eg, plasma-based therapies).

Interim results showed that the incidence of thrombocytopenia events was reduced by 60% (95% CI, 30-70) with TAK-755 compared with SOC. Moreover, a significantly lower proportion of patients experienced adverse events during treatment with TAK-755 (8.9%) vs SOC (47.7%).

Long-term safety and efficacy data from a continuation study (ClinicalTrials.gov Identifier: NCT04683003) were also included in the application.

“TAK-755 is the first and only treatment in clinical development that provides targeted replacement of ADAMTS13, addressing the underlying cause of the disease,” said Daniel Curran, MD, Head, Rare Genetics & Hematology Therapeutic Area Unit at Takeda. “We continue to be encouraged by the data and are working closely with the US FDA and other global regulatory bodies with the goal to bring this treatment to patients.”

TAK-755 has been granted Fast Track, Orphan Drug, and Rare Pediatric Disease designations for this indication.

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Researchers included 622 women with children aged 2 years in the 2-arm, randomized controlled trial conducted between March 2019 and October 2020. Study participants underwent random assignment to the obesity telephone intervention, during which they received a total of 3 support phone calls plus short messages, or to a control group, where they received usual care plus 2 mailed booklets that were unrelated to the intervention. The study duration was 1 year and individuals in the intervention group received the support calls while their children were aged 24 to 26, 28 to 30, and 32 to 34 months.

Primary outcome was BMI at age 3 years, while secondary outcomes included dietary and activity behaviors.

Among the children included in the clinical trial, 470 (71%) had height and weight measures (intervention, n=211; control, n=259). While there were no statistically significant differences in BMI or BMI z-scores between patients who underwent the obesity telephone intervention and the control group (P =.111 and P =.148, respectively), the report shows that the intervention improved dietary and activity behaviors. Children in the intervention group were less likely to eat while watching television (adjusted odds ratio [aOR], 1.79; 95% CI, 1.17-2.73; P =.008), more likely to adhere to dietary recommendations [aOR, 1.73; 95% CI, 0.99-3.02; P =.054) and more likely to meet activity recommendations (aOR, 1.72; 95% CI, 1.11-2.67; P =.015) compared with control group participants.  

A subgroup analysis of children from households with lower incomes (n=149) revealed that the obesity telephone intervention was associated with lower BMI and BMI z-scores (P =.028 and P =.032, respectively). This finding highlights the need for educational initiatives designed to reduce overweight and obesity among this population, the researchers argue.

The use of parent-reported height and weight measures due to COVID-19-related restrictions is an acknowledge limitation to the research.

“[C]hildren from lower socio-economic families and communities are at higher risk of overweight and obesity; arguably, obesity prevention programs should be targeting these socioeconomically disadvantaged families,” according to the study authors.  

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Researchers conducted a retrospective cohort study to assess the frequency of complex hospital courses among children hospitalized with RSV- vs influenza-associated lower respiratory tract infection between 2016 and 2019. Complex hospital courses were considered a composite of pediatric intensive care unit (PICU) admission, respiratory support, nasogastric tube feeds, prolonged hospitalization, and mortality. Secondary outcomes included hospital readmission within 7 days of discharge and time to respiratory support initiation. Outcomes between the groups were compared via multivariable logistic regression, with adjustments for race/ethnicity, sex, age, and gestational age.

Among a total of 1228 patients included in the analysis, 1,094 (89%) were hospitalized with RSV infection and 134 (11%) with influenza infection. Patients with influenza vs RSV infection were older (336 vs 165 days; P < 0.001) and more likely to have abnormal pulse (84.3% vs 73.5%; P < 0.01) and fever (27.6% vs 18.9% P = 0.02). Patients admitted with RSV infection were more likely to be diagnosed with bronchiolitis (98.6%), whereas those admitted with influenza infection were more likely to be diagnosed with viral pneumonia (77.6%).

No significant between-group differences were observed in regard to the number of patients with abnormal age-adjusted respiratory rates, oxygen saturation levels below 92%, and LRTI-related readmission rates at 7 days following hospital discharge.

In the adjusted analysis, the risk for a complex hospital course was significantly higher among patients in the RSV group compared with those in the influenza group (adjusted odds ratio [aOR], 3.5; 95% CI, 2.2-5.6). Further analysis between the groups showed that patients with RSV infection were more likely to require respiratory support (aOR, 4.1; 95% CI, 2.4-6.9), PICU admission (aOR, 2.4; 95% CI, 1.4-4.2), and prolonged hospitalization (adjusted incidence rate ratio, 1.3; 95% CI, 1.1-1.5). However, admissions for RSV were not significantly associated with the occurrence of nasogastric tube feeding (aOR, 2.3; 95% CI, 0.7-8.0) or mortality.

Stratified by age, the increased risk for complex hospital course observed in admissions for RSV vs influenza infection was higher among patients younger than 1 compared with those aged 1 year and older.

Study limitations include the single-center setting, retrospective design, and the inclusion of only patient data captured from electronic health records.

According to the researchers, “[I]dentifying LRTI admissions due to RSV and influenza may guide hospital admission needs, discharge criteria, and aid in providing families with anticipatory guidance regarding the hospitalization.”

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Mediterranean countries are currently reporting the highest numbers of childhood obesity.  Previous research has suggested that infancy growth rates may affect likelihood of obesity.

Researchers aimed to understand the association between growth rates during the first 6 months of life and risk for obesity later in childhood.

Researchers conducted a secondary analysis using data from 2 studies that were conducted among preschool and preadolescent children in Greece.

Data were retrospectively collected from children’s birth certificates, health records, and parental recalls. Health records were used to collect weight for age, length for age, weight for length, and body mass index (BMI). Children’s birth weight was used to categorize participants into small-for-gestational-age, appropriate-for-gestational-age, and large-for-gestational-age. In addition, weight gain was stratified in into poor weight gain, normal weight gain, and rapid weight gain.

Receiver operating curves (ROC) were used to identify optimal cutoff points in the changes in weight and height during the first 6 months of life. Exceeding the cutoff would increase the likelihood of overweight and obesity, with the highest possible sensitivity and specificity.

A higher likelihood of overweight and obesity was observed in infants with rapid weight gain in the first 6 months of life (odds ratio [OR], 1.36; 95% CI, 1.14-1.64). A significant association was also found between poor growth rate and the development of overweight and obesity in preadolescent boys (OR, 1.51; 95% CI, 1.03-2.20).

Changes in weight by age, length for age, and weight for length by 0.54, 0.84, and0.82, respectively, was significantly associated with a lower likelihood of overweight and obesity in preschool years.

In addition, values up to -0.95, 0.09, and 0.23, respectively, were significantly associated with a lower likelihood of development of overweight or obesity in preadolescence.

One of the study limitations was the retrospective recall of perinatal data in both studies and risk for recall bias.

The study authors concluded, “[T]he optimal growth cut-offs identified in the current study could possibly set the basis for healthcare professionals and families to better monitor, assess, and control infant growth rates.”

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Researchers enrolled 120 infants (mean age, 7.24 months) in a cross-sectional study to examine variables associated with vitamin D insufficiency. Full-termed infants, aged 6 to 12 months, underwent blood sampling, demographic assessment, and a 24-hour nutritional assessment. The team recorded 25-hydroxyvitamin (OH) D and hemoglobin (Hb) levels and assess associations between vitamin D insufficiency and anemia as a primary outcome measure. Secondary outcome measures included risk factors for vitamin D insufficiency.

Among the infants included in the study, 35 (29.4%) received an anemia diagnosis and 34 (28.3%) were vitamin D deficient. Iron deficiency anemia was the most common underlying cause of anemia found, constituting 82.8% of those diagnosed.

The mean 25(OH)D levels in the 35 infants with anemia were significantly lower compared with the 84 infants without anemia, making vitamin D insufficiency more prevalent among the infants with anemia (P=0.031). Similarly, investigators noted anemia in 45.4% of participants with vitamin D insufficiency compared with 23.3% of infants who were vitamin D sufficient.

Multivariate regression models found that less than 15 minutes of sunlight exposure per day was a significant risk factor for vitamin D insufficiency (odds ratio [OR], 3.84; 95% CI, 1.23-12.00; P =0.020). Doubling vitamin D intake significantly reduced vitamin D insufficiency risk (OR, 0.37; 95% CI, 0.20– 0.74; P = 0.004). Anemia, breastfeeding and low iron intake did not demonstrate any significant associations with vitamin D insufficiency following multivariate analysis, but infants with these variables were more likely to have vitamin D insufficiency, according to the report.

“Infants require optimal sunlight exposure and vitamin D intake to prevent [vitamin D insufficiency],” according to the study authors. “Given that there are limited recommendations on appropriate sunlight exposure for infants and low vitamin D in natural food sources, including breast milk, vitamin D supplementation should be provided.”

Study limitations include a small sample size, single center design, a disproportionate representation of families with high incomes, and failure to obtain iron status markers.

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The investigators assessed the relationship between RSV infection in infancy and childhood asthma through analysis of the Infant Susceptibility to Pulmonary Infections and Asthma Following RSV Exposure (INSPIRE) cohort, a US population-based birth cohort that enrolled infants from birth to age 4 months from 11 pediatric practices in Tennessee.

All children included for analysis were healthy, born at term, had a birthweight of at least 2250 g, and were born from June to December 2012 or June to December 2013. Each child underwent passive and active surveillance during the first RSV season. The primary outcome was 5-year current asthma, which was defined as a parental report of physician-diagnosed asthma or use of asthma medications at any time before age 5 years and any of the following symptoms in the year before the 5-year well visit: asthma symptoms, asthma-related systemic steroid use, or acute health care use for asthma.

A total of 1741 (89%) of 1946 eligible children (median age, 55 [interquartile range, 16-78] days; 52% male) had available data to assess their RSV infection status during their first year of life. Of this group, 944 children had RSV infection in infancy (54%; 95% CI, 52-57). The infants with no RSV infection were more likely to be non-Hispanic White, enrolled at a younger age, born vaginally, and more likely to have not attended day care or lived with another child aged <6 years, compared with infants with RSV infection.

The number of children with available follow-up data who had 5-year current asthma was 238 of 1309 (18%). The proportion of those with 5-year current asthma was lower for children with no RSV infection during infancy (91 [16%] of 587 infants) vs infants with RSV infection (139 [21%] of 670 infants). Children who did not have RSV in infancy had a 26% reduced risk of 5-year current asthma compared with those with RSV infection during infancy (adjusted risk ratio [RR], 0.74; 95% CI, 0.58-0.94; P =.014). The estimated proportion of 5-year current asthma cases that could be prevented by avoiding RSV infection in infancy was 15% (95% CI, 2.2-26.8; preventable fraction of 0.15 [0.02-0.27]).

A sensitivity analysis of 810 children showed an almost identical effect size in a comparison of those with a positive nasal wash for RSV by reverse transcription-quantitative polymerase chain reaction (RT-qPCR) vs those who had a negative nasal wash for RSV by RT-qPCR (adjusted RR, 0.76; 95% CI, 0.58-1.00; P =.051).

In an analysis of 237 infants with an in-person respiratory illness assessment and a positive nasal wash for RSV by RTqPCR and 5-year current asthma data, a positive association was found between RSV infection severity in infancy (as measured by the Respiratory Severity Score) and the risk of 5-year current asthma (adjusted odds ratio, 1.24; 95% CI, 1.05-1.45; P =.0092).

Of 194 children with 5-year current asthma and blood-specific IgE testing at age 3 years, 102 (53%) had atopic asthma and 92 (47%) had nonatopic asthma.

The proportion of children with recurrent wheeze was reduced in those with no RSV infection during infancy vs those with RSV infection at each of the measured timepoints between ages 1 and 4 years. Repeated outcome analyses showed that the association between RSV infection in infancy and recurrent wheeze during preschool years (ages 1-4 years) varied over time (P_interaction =.026). When stratified by child age, infants with no RSV infection had a reduced risk of recurrent wheeze annually compared with infants with RSV infection, although it was only significant for 1-year and 2-year recurrent wheeze.

Limitations include the potential misclassification of children categorized as not infected with RSV in infancy and the lack of a standard definition of childhood asthma. Also, the relationship between being infected with RSV during infancy and childhood asthma could have been confounded by unmeasured factors.

“Our results highlight the need for long-term follow-up of common respiratory outcomes among children participating in ongoing and future clinical trials of agents for RSV immunoprophylaxis,” the investigators stated.

Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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