Significant delays exist in industry-sponsored pediatric clinical drug trial start-up and enrollment processes.

Background: Significant barriers to advancing pediatric drug development continue despite federal incentives to expedite pediatric drug development. There is an urgent need to improve how clinical trials are designed, implemented, and conducted to increase the number of approved therapeutic interventions for children.

Methods: The Pediatric Improvement Collaborative for Clinical Trials & Research was created to measure timelines and address delays in the pediatric clinical trials process.

Diagnosing, managing, and studying long-COVID syndromes in children and adolescents in rural and underserved populations.

The COVID-19 pandemic has arguably had its greatest impact in rural and other historically hard-to-reach populations. Families in rural and underserved communities experienced COVID-19 infections at a higher rate than did their peers in other groups and experienced disproportionate morbidity and mortality. Without careful design and implementation of resources, children in these areas are also at risk of being disproportionately affected by long-term sequelae of SARS-CoV-2 infections, such as "long COVID" syndromes.

The Fate of the Left Ventricular Outflow Tract Following Interrupted Aortic Arch Repair.

To examine the probability of left ventricular outflow tract (LVOT) reintervention following interrupted aortic arch (IAA) repair in neonates with LVOT obstruction (LVOTO) risk. This retrospective multicenter study included 150 neonates who underwent IAA repair (2003-2017); 100 of 150 (67%) had isolated IAA repair (with ventricular septal defect closure) and 50 of 150 (33%) had concomitant LVOT intervention: conal muscle resection (n = 16), Ross-Konno (n = 7), and Yasui operation (n = 27: single-stage n = 8, staged n = 19). Demographic and morphologic characteristics were reviewed.

Caregiver Intent and Willingness to Accept COVID-19 Vaccine in the Pediatric Emergency Department.

Background: While COVID-19 vaccine (CV) acceptance is improving, little is known about parental acceptance of CV in the pediatric emergency department (PED).

Objectives: The aims of the study are to assess rates of CV uptake among eligible children presenting to the PED, describe caregiver willingness to accept CV in the PED, and assess potential ED-based interventions to increase CV acceptance.

Methods: We surveyed caregivers of 384 children aged ≥6 months presenting to the PED for minor illness/injury.

Outcomes of heart transplantation in children with previously palliated hypoplastic left heart syndrome.

Objectives: Paediatric heart transplantation in children who fail multistage palliation for hypoplastic left heart syndrome is associated with challenges related to immune, clinical or anatomic risk factors. We review current outcomes and risk factors for survival following heart transplantation in this challenging patient population.

Methods: The United Network for Organ Sharing transplantation database was merged with Paediatric Health Information System database to identify children who received heart transplantation following prior palliation for hypoplastic left heart syndrome.

Trends and outcomes of heart transplantation in adults with congenital heart disease.

Objectives: Heart transplantation for adult congenital heart disease is complicated and associated with challenging pretransplant support, long waiting and high early post-transplant mortality. We explored if surgical and medical advances and allocation system changes have affected outcomes.

Methods: From United Network for Organ Sharing database, adults with congenital heart disease listed for heart transplantation were queried.

Survival does not differ by annual center transplant volume-A Pediatric Heart Transplant Society Registry study.

Background: There are conflicting data regarding the relationship between center volume and outcomes in pediatric heart transplantation. Previous studies have not fully accounted for differences in case mix, particularly in high-risk congenital heart disease (CHD) groups. We aimed to evaluate the relationship between center volume and outcomes using the Pediatric Heart Transplant Society (PHTS) Registry and explore how case mix may affect outcomes.

The American Association for Thoracic Surgery (AATS) 2023 Expert Consensus Document: Recommendation for the care of children with trisomy 13 or trisomy 18 and a congenital heart defect.

Objectives: Recommendations for surgical repair of a congenital heart defect in children with trisomy 13 or trisomy 18 remain controversial, are subject to biases, and are largely unsupported with limited empirical data. This has created significant distrust and uncertainty among parents and could potentially lead to suboptimal care for patients. A working group, representing several clinical specialties involved with the care of these children, developed recommendations to assist in the decision-making process for congenital heart defect care in this population.

Increasing donor-recipient weight mismatch in infant heart transplantation is associated with shorter waitlist duration and no increased morbidity or mortality.

Objectives: Infants awaiting paediatric heart transplantation (PHT) experience long waitlist duration and high mortality due to donor shortage. Using the United Network for Organ Sharing database, we explored if increasing donor-recipient weight ratio (DRWR) >2.0 (recommended cutoff) was associated with adverse outcomes.

Pharmacokinetics of Oral Vitamin D in Children with Obesity and Asthma.

Background And Objective: Vitamin D insufficiency is common in several pediatric diseases including obesity and asthma. Little data exist describing the pharmacokinetics of oral vitamin D in children or the optimal dosing to achieve therapeutic 25(OH)D targets. Describe the pharmacokinetics of oral Vitamin D in children with asthma.

Infants Admitted to US Intensive Care Units for RSV Infection During the 2022 Seasonal Peak.

Importance: Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infections (LRTIs) and infant hospitalization worldwide.

Objective: To evaluate the characteristics and outcomes of RSV-related critical illness in US infants during peak 2022 RSV transmission.

Design, Setting, And Participants: This cross-sectional study used a public health prospective surveillance registry in 39 pediatric hospitals across 27 US states.

Ketamine Use in the Intubation of Critically Ill Children with Neurological Indications: A Multicenter Retrospective Analysis.

Background: Ketamine has traditionally been avoided for tracheal intubations (TIs) in patients with acute neurological conditions. We evaluate its current usage pattern in these patients and any associated adverse events.

Methods: We conducted a retrospective observational cohort study of critically ill children undergoing TI for neurological indications in 53 international pediatric intensive care units and emergency departments.

Prehospital and emergency department pediatric readiness for injured children: A statement from the American College of Surgeons Committee on Trauma Emergency Medical Services Committee.

Injury is the leading cause of death in children older than 1 year, and children make up 22% of the population. Pediatric readiness (PR) of the nation's emergency departments and state trauma and emergency medical services (EMS) systems is conceptually important and vital to mitigate mortality and morbidity in this population. The extension of PR to the trauma community has become a focused area for training, staffing, education, and equipment at all levels of trauma center designation, and there is evidence that a higher level of emergency department PR is independently associated with long-term survival among injured children.

Setting an Agenda: Results of a Consensus Process on Research Directions in Distance Simulation.

Background: The COVID-19 pandemic forced rapid implementation and refinement of distance simulation methodologies in which participants and/or facilitators are not physically colocated. A review of the distance simulation literature showed that heterogeneity in many areas (including nomenclature, methodology, and outcomes) limited the ability to identify best practice. In April 2020, the Healthcare Distance Simulation Collaboration was formed with the goal of addressing these issues.

Associated Factors and Impact of Persistent Renal Dysfunction in Pediatric Heart Transplantation.

Background: We evaluated the impact of significant renal dysfunction (SRD) on listing and pediatric heart transplantation (PHT) outcomes.

Methods: The United Network of Organ Sharing registry was queried. Our cohort included 11,625 children listed for PHT (2000-2020).

Association of Early Steroid Administration With Outcomes of Children Hospitalized for COVID-19 Without Multisystem Inflammatory Syndrome in Children.

Importance: There is limited evidence for therapeutic options for pediatric COVID-19 outside of multisystem inflammatory syndrome in children (MIS-C).

Objective: To determine whether the use of steroids within 2 days of admission for non-MIS-C COVID-19 in children is associated with hospital length of stay (LOS). The secondary objective was to determine their association with intensive care unit (ICU) LOS, inflammation, and fever defervescence.

Test-to-Stay After SARS-CoV-2 Exposure: A Mitigation Strategy for Optionally Masked K-12 Schools.

Objectives: We evaluated the impact of a test-to-stay (TTS) program on within-school transmission and missed school days in optionally masked kindergarten through 12th grade schools during a period of high community severe acute respiratory syndrome coronavirus 2 transmission.

Methods: Close contacts of those with confirmed severe acute respiratory syndrome coronavirus 2 infection were eligible for enrollment in the TTS program if exposure to a nonhousehold contact occurred between November 11, 2021 and January 28, 2022. Consented participants avoided school exclusion if they remained asymptomatic and rapid antigen testing at prespecified intervals remained negative.

Gastrointestinal Manifestations in Hospitalized Children With Acute SARS-CoV-2 Infection and Multisystem Inflammatory Condition: An Analysis of the VIRUS COVID-19 Registry.

Background: Describe the incidence and associated outcomes of gastrointestinal (GI) manifestations of acute coronavirus disease 2019 (COVID-19) and multisystem inflammatory syndrome in hospitalized children (MIS-C).

Methods: Retrospective review of the Viral Infection and Respiratory Illness Universal Study registry, a prospective observational, multicenter international cohort study of hospitalized children with acute COVID-19 or MIS-C from March 2020 to November 2020. The primary outcome measure was critical COVID-19 illness.

Test-to-Stay After Exposure to SARS-CoV-2 in K-12 Schools.

Objectives: We evaluated the safety and efficacy of a test-to-stay program for unvaccinated students and staff who experienced an unmasked, in-school exposure to someone with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Serial testing instead of quarantine was offered to asymptomatic contacts. We measured secondary and tertiary transmission rates within participating schools and in-school days preserved for participants.

Facilitators and barriers to pediatric clinical trial recruitment and retention in rural and community settings: A scoping review of the literature.

Children in rural settings are under-represented in clinical trials, potentially contributing to rural health disparities. We performed a scoping review describing available literature on barriers and facilitators impacting participation in pediatric clinical trials in rural and community-based (nonclinical) settings. Articles identified via PubMed, CINAHL, Embase, and Web of Science were independently double-screened at title/abstract and full-text levels to identify articles meeting eligibility criteria.

Pharmacokinetics of Ceftazidime in Children and Adolescents with Obesity.

Purpose: The aim of this study was to evaluate ceftazidime pharmacokinetics (PK) in a cohort that includes a predominate number of children and adolescents with obesity and assess the efficacy of competing dosing strategies.

Methods: A population PK model was developed using opportunistically collected plasma samples. For each dosing strategy, model-based probability of target attainment (PTA) estimates were computed for study participants using empirical Bayes estimates.

The Impact of Obesity on Disease Severity and Outcomes Among Hospitalized Children With COVID-19.

Objective: To describe the impact of obesity on disease severity and outcomes of coronavirus disease 2019 (COVID-19) among hospitalized children.

Methods: This retrospective cohort study from the Society of Critical Care Medicine Viral Respiratory Illness Universal Study registry included all children hospitalized with COVID-19 from March 2020 to January 2021. Obesity was defined by Centers for Disease Control and Prevention BMI or World Health Organization weight for length criteria.