PEDIATRICS recent issues

Oral Ondansetron Administration to Dehydrated Children in Pakistan: A Randomized Clinical Trial

BACKGROUND:

Ondansetron is an effective antiemetic employed to prevent vomiting in children with gastroenteritis in high-income countries; data from low- and middle-income countries are sparse.

METHODS:

We conducted a randomized, double-blind, placebo-controlled superiority trial in 2 pediatric emergency departments in Pakistan. Dehydrated children aged 6 to 60 months with ≥1 diarrheal (ie, loose or liquid) stool and ≥1 vomiting episode within the preceding 4 hours were eligible to participate. Participants received a single weight-based dose of oral ondansetron (8–15 kg: 2 mg; >15 kg: 4 mg) or identical placebo. The primary outcome was intravenous administration of ≥20 mL/kg over 4 hours of an isotonic fluid within 72 hours of random assignment.

RESULTS:

All 918 (100%) randomly assigned children completed follow-up. Intravenous rehydration was administered to 14.7% (68 of 462) and 19.5% (89 of 456) of those administered ondansetron and placebo, respectively (difference: –4.8%; 95% confidence interval [CI], –9.7% to 0.0%). In multivariable logistic regression analysis adjusted for other antiemetic agents, antibiotics, zinc, and the number of vomiting episodes in the preceding 24 hours, children administered ondansetron had lower odds of the primary outcome (odds ratio: 0.70; 95% CI, 0.49 to 1.00). Fewer children in the ondansetron, relative to the placebo group vomited during the observation period (difference: –12.9%; 95% CI, –18.0% to –7.8%). The median number of vomiting episodes (P < .001) was lower in the ondansetron group.

CONCLUSIONS:

Among children with gastroenteritis-associated vomiting and dehydration, oral ondansetron administration reduced vomiting and intravenous rehydration use. Ondansetron use may be considered to promote oral rehydration therapy success among dehydrated children in low- and middle-income countries.

Systemic Artery Aneurysms and Kawasaki Disease

BACKGROUND:

Coronary artery aneurysms (CAAs) are a well-known complication of Kawasaki disease (KD), but there are no data on incidence or outcomes of systemic artery aneurysms (SAAs) in the current era.

METHODS:

From April 1, 2016, to March 31, 2019, we screened for SAAs in 162 patients with KD at risk for SAAs with magnetic resonance angiography or peripheral angiography and analyzed incidence and early outcomes of SAAs.

RESULTS:

Twenty-three patients had SAAs, demonstrating an incidence of 14.2% (23 of 162) in patients who were screened at 1 month after onset. The proportion of patients with SAAs was estimated to be 2% (23 of 1148) of all patients with KD. The median age at onset of KD with SAAs was 5 months. All patients with SAAs had CAAs, with z scores >8. Of patients with giant CAAs, 38.6% (17 of 44) had SAAs. A total of 129 SAAs occurred in 17 different named arteries. The most common sites for SAAs were the axillary (18.6%), common iliac (12.4%), and brachial (11.6%) arteries. During a median follow-up time of 6 months, 92.9% (79 of 85) of SAAs had some degree of regression, with 80% (68 of 85) of SAAs returning to normal. The overall regression rate was higher for medium to large SAAs than for medium to giant CAAs.

CONCLUSIONS:

Although the incidence of SAAs may not be as dramatically reduced as we expected compared with previous data, SAAs have a high regression rate during short-term follow-up.

Pediatrician Perspectives on Feasibility and Acceptability of the MOCA-Peds 2017 Pilot

BACKGROUND AND OBJECTIVES:

The American Board of Pediatrics (ABP) certifies that general and subspecialty pediatricians meet standards of excellence established by their peers, immediately after training and over the course of their careers (ie, Maintenance of Certification [MOC]). In 2015–2016, the ABP developed the Maintenance of Certification Assessment for Pediatrics (MOCA-Peds) as an alternative assessment to the current proctored, closed-book general pediatrics (GP) MOC examination. This article is 1 of a 2-part series examining results from the MOCA-Peds pilot in 2017.

METHODS:

We conducted quantitative and qualitative analyses with 5081 eligible pediatricians who registered to participate in the 2017 pilot; 81.4% (n = 4016) completed a quarter 4 survey and/or end-of-year survey (January 2018) and comprise the analytic sample.

RESULTS:

The majority of pediatricians considered the MOCA-Peds to be feasible and acceptable as an alternative to the proctored MOC GP examination. More than 90% of respondents indicated they would participate in the proposed MOCA-Peds model instead of the examination. Participants also offered recommendations to improve the MOCA-Peds (eg, enhanced focus of questions on outpatient GP, references provided before taking questions); the ABP is carefully considering these as the MOCA-Peds is further refined.

CONCLUSIONS:

Pilot participant feedback in 2017 suggested that the MOCA-Peds could be implemented for GP starting in January 2019, with all 15 subspecialties launched by 2022. Current and future evaluations will continue to explore feasibility, acceptability, and learning and practice change as well as sustainability of participation.

Pediatrician Perspectives on Learning and Practice Change in the MOCA-Peds 2017 Pilot

BACKGROUND AND OBJECTIVES:

This article is the second of a 2-part series examining results regarding self-reported learning and practice change from the American Board of Pediatrics 2017 pilot of an alternative to the proctored, continuing certification examination, termed the Maintenance of Certification Assessment for Pediatrics (MOCA-Peds). Because of its design, MOCA-Peds has several learning advantages compared with the proctored examination.

METHODS:

Quantitative and qualitative analyses with 5081 eligible pediatricians who registered to participate in the 2017 pilot; 81.4% (n = 4016) completed a quarter 4 survey and/or the end-of-year survey (January 2018) and compose the analytic sample.

RESULTS:

Nearly all (97.6%) participating pediatricians said they had learned, refreshed, or enhanced their medical knowledge, and of those, 62.0% had made a practice change related to pilot participation. Differences were noted on the basis of subspecialty status, with 68.9% of general pediatricians having made a practice change compared with 41.4% of subspecialists. Within the 1456 open-ended responses about participants’ most significant practice change, responses ranged widely, including both medical care content (eg, "care for corneal abrasions altered," "better inform patients about. . .flu vaccine") and nonspecific content (eg, providing better patient education, using evidence-based medicine, increased use of resources in regular practice).

CONCLUSIONS:

As a proctored examination alternative, MOCA-Peds positively influenced self-reported learning and practice change. In future evaluation of MOCA-Peds and other medical longitudinal assessments, researchers should study ways to further encourage learning and practice change and sustainability.

Weight Loss and Illness Severity in Adolescents With Atypical Anorexia Nervosa

BACKGROUND:

Lower weight has historically been equated with more severe illness in anorexia nervosa (AN). Reliance on admission weight to guide clinical concern is challenged by the rise in patients with atypical anorexia nervosa (AAN) requiring hospitalization at normal weight.

METHODS:

We examined weight history and illness severity in 12- to 24-year-olds with AN (n = 66) and AAN (n = 50) in a randomized clinical trial, the Study of Refeeding to Optimize Inpatient Gains (www.clinicaltrials.gov; NCT02488109). Amount of weight loss was the difference between the highest historical percentage median BMI and admission; rate was the amount divided by duration (months). Unpaired t tests compared AAN and AN; multiple variable regressions examined associations between weight history variables and markers of illness severity at admission. Stepwise regression examined the explanatory value of weight and menstrual history on selected markers.

RESULTS:

Participants were 16.5 ± 2.6 years old, and 91% were of female sex. Groups did not differ by weight history or admission heart rate (HR). Eating Disorder Examination Questionnaire global scores were higher in AAN (mean 3.80 [SD 1.66] vs mean 3.00 [SD 1.66]; P = .02). Independent of admission weight, lower HR (β = –0.492 [confidence interval (CI) –0.883 to –0.100]; P = .01) was associated with faster loss; lower serum phosphorus was associated with a greater amount (β = –0.005 [CI –0.010 to 0.000]; P = .04) and longer duration (β = –0.011 [CI –0.017 to 0.005]; P = .001). Weight and menstrual history explained 28% of the variance in HR and 36% of the variance in serum phosphorus.

CONCLUSIONS:

Weight history was independently associated with markers of malnutrition in inpatients with restrictive eating disorders across a range of body weights and should be considered when assessing illness severity on hospital admission.

Children With Minor Blunt Head Trauma Presenting to the Emergency Department

In our state-of-the-art review, we summarize the best-available evidence for the optimal emergency department management of children with minor blunt head trauma. Minor blunt head trauma in children is a common reason for emergency department evaluation, although clinically important traumatic brain injuries (TBIs) as a result are uncommon. Cranial computed tomography (CT) scanning is the reference standard for the diagnosis of TBIs, although they should be used judiciously because of the risk of lethal malignancy from ionizing radiation exposure, with the greatest risk to the youngest children. Available TBI prediction rules can assist with CT decision-making by identifying patients at either low risk for TBI, for whom CT scans may safely be obviated, or at high risk, for whom CT scans may be indicated. For clinical prediction rules to change practice, however, they require active implementation. Observation before CT decision-making in selected patients may further reduce CT rates without missing children with clinically important TBIs. Future work is also needed to incorporate patient and family preferences into these decision-making algorithms when the course of action is not clear.

Kingella kingae and Osteoarticular Infections

OBJECTIVES:

In this study, we aimed to contrast the bacteriologic epidemiology of osteoarticular infections (OAIs) between 2 patient groups in successive 10-year periods, before and after the extensive use of nucleic acid amplification assays in the diagnostic process.

METHODS:

Epidemiologic data and bacteriologic etiologies of all children presenting with OAIs on admission to our institution over 20 years (1997–2016) were assessed retrospectively. The population was divided into 2 cohorts, using the standardized use of polymerase chain reaction as the cutoff point (2007). The conventional cohort included children with OAIs mainly investigated by using classic cultures, whereas the molecular cohort referred to patients also investigated by using molecular assays.

RESULTS:

Kingella kingae was the most frequently isolated pathogen, responsible for 51% of OAIs, whereas other classic pathogens were responsible for 39.7% of cases in the molecular cohort. A statistically significant increase in the mean incidence of OAIs was observed, as was a decrease in the mean age at diagnosis after 2007. After 2007, the pathogen remained unidentified in 21.6% of OAIs in our pediatric population.

CONCLUSIONS:

Extensive use of nucleic acid amplification assays improved the detection of fastidious pathogens and has increased the observed incidence of OAI, especially in children aged between 6 and 48 months. We propose the incorporation of polymerase chain reaction assays into modern diagnostic algorithms for OAIs to better identify the bacteriologic etiology of OAIs.

Vaccine Oka Varicella Meningitis in Two Adolescents

The live-attenuated varicella vaccine, a routine immunization in the United States since 1995, is both safe and effective. Like wild-type varicella-zoster virus, however, vaccine Oka (vOka) varicella can establish latency and reactivate as herpes zoster, rarely leading to serious disease, particularly among immunocompromised hosts. Previous cases of reactivated vOka resulting in meningitis have been described in young children who received a single dose of varicella vaccine; less is known about vOka reactivation in older children after the 2-dose vaccine series. We present 2 adolescents with reactivated vOka meningitis, 1 immunocompetent and 1 immunocompromised, both of whom received 2 doses of varicella vaccine many years before as children. Pediatricians should be aware of the potential of vOka varicella to reactivate and cause clinically significant central nervous system disease in vaccinated children and adolescents.

Growth and Distribution of Child Psychiatrists in the United States: 2007-2016

BACKGROUND:

Historically, there has been a shortage of child psychiatrists in the United States, undermining access to care. This study updated trends in the growth and distribution of child psychiatrists over the past decade.

METHODS:

Data from the Area Health Resource Files were used to compare the number of child psychiatrists per 100 000 children ages 0 to 19 between 2007 and 2016 by state and county. We also examined sociodemographic characteristics associated with the density of child psychiatrists at the county level over this period using negative binomial multivariable models.

RESULTS:

From 2007 to 2016, the number of child psychiatrists in the United States increased from 6590 to 7991, a 21.3% gain. The number of child psychiatrists per 100 000 children also grew from 8.01 to 9.75, connoting a 21.7% increase. County- and state-level growth varied widely, with 6 states observing a decline in the ratio of child psychiatrists (ID, IN, KS, ND, SC, and SD) and 6 states increasing by >50% (AK, AR, NH, NV, OK, and RI). Seventy percent of counties had no child psychiatrists in both 2007 and 2016. Child psychiatrists were significantly more likely to practice in high-income counties (P < .001), counties with higher levels of postsecondary education (P < .001), and metropolitan counties compared with those adjacent to metropolitan regions (P < .05).

CONCLUSIONS:

Despite the increased ratio of child psychiatrists per 100 000 children in the United States over the past decade, there remains a dearth of child psychiatrists, particularly in parts of the United States with lower levels of income and education.

A National Approach to Pediatric Sepsis Surveillance

Pediatric sepsis is a major public health concern, and robust surveillance tools are needed to characterize its incidence, outcomes, and trends. The increasing use of electronic health records (EHRs) in the United States creates an opportunity to conduct reliable, pragmatic, and generalizable population-level surveillance using routinely collected clinical data rather than administrative claims or resource-intensive chart review. In 2015, the US Centers for Disease Control and Prevention recruited sepsis investigators and representatives of key professional societies to develop an approach to adult sepsis surveillance using clinical data recorded in EHRs. This led to the creation of the adult sepsis event definition, which was used to estimate the national burden of sepsis in adults and has been adapted into a tool kit to facilitate widespread implementation by hospitals. In July 2018, the Centers for Disease Control and Prevention convened a new multidisciplinary pediatric working group to tailor an EHR-based national sepsis surveillance approach to infants and children. Here, we describe the challenges specific to pediatric sepsis surveillance, including evolving clinical definitions of sepsis, accommodation of age-dependent physiologic differences, identifying appropriate EHR markers of infection and organ dysfunction among infants and children, and the need to account for children with medical complexity and the growing regionalization of pediatric care. We propose a preliminary pediatric sepsis event surveillance definition and outline next steps for refining and validating these criteria so that they may be used to estimate the national burden of pediatric sepsis and support site-specific surveillance to complement ongoing initiatives to improve sepsis prevention, recognition, and treatment.

Safety of the 9-Valent Human Papillomavirus Vaccine

BACKGROUND:

The 9-valent human papillomavirus vaccine (9vHPV) was approved for females and males aged 9 to 26 years in 2014. We analyzed postlicensure surveillance reports to the Vaccine Adverse Event Reporting System (VAERS).

METHODS:

We searched VAERS data for US reports of adverse events (AEs) after 9vHPV from December 2014 through December 2017. We calculated reporting rates and conducted empirical Bayesian data mining to identify disproportional reporting. Physicians reviewed reports for selected prespecified conditions.

RESULTS:

VAERS received 7244 reports after 9vHPV: 31.2% among females, 21.6% among males, and for 47.2%, sex was not reported. Overall, 97.4% of reports were nonserious. Dizziness, syncope, headache, and injection site reactions were most commonly reported; the most commonly reported AEs were similar between females and males. Two reports of death after 9vHPV were verified; no information in autopsy reports or death certificates suggested a causal relationship with vaccination. Approximately 28 million 9vHPV doses were distributed during the study period; crude AE reporting rates were 259 reports per million 9vHPV doses distributed for all reports and 7 per million doses distributed for serious reports. Syncope (a known AE associated with human papillomavirus vaccination) and several types of vaccine administration errors (eg, administered at wrong age) exceeded the statistical threshold for empirical Bayesian data mining findings.

CONCLUSIONS:

No new or unexpected safety concerns or reporting patterns of 9vHPV with clinically important AEs were detected. The safety profile of 9vHPV is consistent with data from prelicensure trials and from postmarketing safety data of its predecessor, the quadrivalent human papillomavirus vaccine.

Near Real-Time Surveillance to Assess the Safety of the 9-Valent Human Papillomavirus Vaccine

BACKGROUND AND OBJECTIVES:

Human papillomavirus is the most common sexually transmitted infection in the United States and causes certain anogenital and oropharyngeal cancers. The 9-valent human papillomavirus vaccine (9vHPV) provides protection against additional types not included in the quadrivalent vaccine. We conducted near real-time vaccine safety surveillance for 24 months after the vaccine became available in the Vaccine Safety Datalink.

METHODS:

Immunizations and adverse events were extracted weekly from October 2015 to October 2017 from standardized data files for persons 9 to 26 years old at 6 Vaccine Safety Datalink sites. Prespecified adverse events included anaphylaxis, allergic reaction, appendicitis, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, injection site reaction, pancreatitis, seizure, stroke, syncope, and venous thromboembolism. The observed and expected numbers of events after 9vHPV were compared weekly by using sequential methods. Both historical and concurrent comparison groups were used to identify statistical signals for adverse events. Unexpected signals were investigated by medical record review and/or additional analyses.

RESULTS:

During 105 weeks of surveillance, 838 991 doses of 9vHPV were administered. We identified unexpected statistical signals for 4 adverse events: appendicitis among boys 9 to 17 years old after dose 3; pancreatitis among men 18 to 26 years old; and allergic reactions among girls 9 to 17 years old and women 18 to 26 years old after dose 2. On further evaluation, which included medical record review, temporal scan analysis, and additional epidemiological analyses, we did not confirm signals for any adverse events.

CONCLUSIONS:

After 2 years of near real-time surveillance of 9vHPV and several prespecified adverse events, no new safety concerns were identified.

Ethical Issues in Newborn Sequencing Research: The Case Study of BabySeq

The BabySeq Project is a study funded by the National Institutes of Health and aimed at exploring the medical, behavioral, and economic impacts of integrating genomic sequencing into the care of both healthy newborns and newborns who are sick. Infants were randomly assigned to receive standard of care or standard of care plus sequencing. The protocol and consent specified that only childhood-onset conditions would be returned. When 1 child was found to carry a BRCA2 mutation despite a negative family history, the research team experienced moral distress about nondisclosure and sought institutional review board permission to disclose. The protocol was then modified to require participants to agree to receive results for adult-onset-only conditions as a precondition to study enrollment. The BabySeq team asserted that their new protocol was in the child’s best interest because having one’s parents alive and well provides both an individual child benefit and a "family benefit." We begin with a short description of BabySeq and the controversy regarding predictive genetic testing of children for adult-onset conditions. We then examine the ethical problems with (1) the revised BabySeq protocol and (2) the concept of family benefit as a justification for the return of adult-onset-only conditions. We reject family benefit as a moral reason to expand genomic sequencing of children beyond conditions that present in childhood. We also argue that researchers should design their pediatric studies to avoid, when possible, identifying adult-onset-only genetic variants and that parents should not be offered the return of this information if discovered unless relevant for the child’s current or imminent health.

When Specialty Care Is Unavailable to Rural Families

We present the case of a 2-year-old boy with epidermolysis bullosa and supraglottic stenosis whose parents refuse an elective tracheostomy because of the significant care the tracheostomy would require. The patient’s family lives in a rural area with few health care resources and his parents are already handling hours of daily skin care for his epidermolysis bullosa. In an attempt to convince the parents to pursue the intervention, the medical team recommends that the family move to an area with additional resources to assist in the child’s care. The parents refuse to move, citing the many benefits their home environment provides for their son. The medical team calls an ethics consultation, questioning whether this decision constitutes medical neglect. This case raises important questions about medical decision-making in pediatrics. First, is a parent’s refusal of a recommended medical intervention because it would require moving their family to a new environment a reasonable decision? Second, how broadly can parents define their child’s best interest? Should only physical interests be included when making medical decisions? Is there a limit to what can be considered a relevant interest? Third, can parents only consider the interests of the individual child, or can they consider the interests of other members of the family? Finally, what is the threshold for overruling a parental decision? Is it whenever the parent’s definition of a patient’s best interest is different from the medical team’s, or do other criteria have to be met?

Timing of Complementary Feeding Introduction and Adiposity Throughout Childhood

OBJECTIVES:

To examine associations of the timing of complementary feeding (CF) introduction with adiposity throughout childhood.

METHODS:

We studied 1013 children from Project Viva. Our exposure was CF introduction, categorized as <4 months (19%), 4 to <6 months (68%; reference group), and ≥6 months of age (14%). Our outcomes included adiposity measures in midchildhood (mean: 7.9 years; SD 0.8; n = 896) and early adolescence (mean: 13.2 years; SD 0.9; n = 850). We used linear regression models adjusted for potential confounders and ran separate models for infants who were breastfed at least partly for ≥4 months (categorized as breastfed; 69%) and infants who were never breastfed or stopped breastfeeding at <4 months (categorized as formula fed; 31%).

RESULTS:

CF initiated at <4 months was associated with higher adiposity in midchildhood in breastfed children; associations persisted into adolescence for waist circumference, truncal fat mass, and the sum of subscapular and triceps skinfolds (eg, waist circumference: confounder-adjusted β 2.97 [95% confidence interval (CI) 0.47 to 5.47] cm). The effect estimates were larger in formula-fed children, with more associations persisting into adolescence (eg, waist circumference: adjusted β 3.42 [95% CI 0.12 to 6.71] cm). CF initiated at ≥6 months was associated with a higher subscapular/triceps skinfold ratio in midchildhood and adolescence (adjusted β 0.13 [95% CI 0.02 to 0.25]) in formula-fed children.

CONCLUSIONS:

We found associations of early CF introduction with higher adiposity measurements in breastfed and formula-fed children and associations of late introduction of CF with higher adiposity in formula-fed children.

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