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Background: We investigated the association between chronic pediatric neurological conditions and the severity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)., Methods: This matched retrospective case-control study includes patients (n = 71,656) with chronic complex neurological disorders under 18 years of age, with laboratory-confirmed diagnosis of COVID-19 or a diagnostic code indicating infection or exposure to SARS-CoV-2, from 103 health systems in the United States. The primary outcome was the severity of coronavirus disease 2019 (COVID-19), which was classified as severe (invasive oxygen therapy or death), moderate (noninvasive oxygen therapy), or mild/asymptomatic (no oxygen therapy). A cumulative link mixed effects model was used for this study., Results: In this study, a cumulative link mixed effects model (random intercepts for health systems and patients) showed that the following classes of chronic neurological disorders were associated with higher odds of severe COVID-19: muscular dystrophies and myopathies (OR = 3.22; 95% confidence interval [CI]: 2.73 to 3.84), chronic central nervous system disorders (OR = 2.82; 95% CI: 2.67 to 2.97), cerebral palsy (OR = 1.97; 95% CI: 1.85 to 2.10), congenital neurological disorders (OR = 1.86; 95% CI: 1.75 to 1.96), epilepsy (OR = 1.35; 95% CI: 1.26 to 1.44), and intellectual developmental disorders (OR = 1.09; 95% CI: 1.003 to 1.19). Movement disorders were associated with lower odds of severe COVID-19 (OR = 0.90; 95% CI: 0.81 to 0.99)., Conclusions: Pediatric patients with chronic neurological disorders are at higher odds of severe COVID-19. Movement disorders were associated with lower odds of severe COVID-19., Competing Interests: Declaration of competing interest None., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objectives: Data on coronavirus disease 2019 (COVID-19) infections in neonates are limited. We aimed to identify and describe the incidence, presentation, and clinical outcomes of neonatal COVID-19., Methods: Over 1 million neonatal encounters at 109 United States health systems, from March 2020 to February 2021, were extracted from the Cerner Real World Database. COVID-19 diagnosis was assessed using severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) laboratory tests and diagnosis codes. Incidence of COVID-19 per 100 000 encounters was estimated., Results: COVID-19 was diagnosed in 918 (0.1%) neonates (91.1 per 100 000 encounters [95% confidence interval 85.3-97.2]). Of these, 71 (7.7%) had severe infection (7 per 100 000 [95% confidence interval 5.5-8.9]). Median time to diagnosis was 14.5 days from birth (interquartile range 3.1-24.2). Common signs of infection were tachypnea and fever. Those with severe infection were more likely to receive respiratory support (50.7% vs 5.2%, P < .001). Severely ill neonates received analgesia (38%), antibiotics (33.8%), anticoagulants (32.4%), corticosteroids (26.8%), remdesivir (2.8%), and COVID-19 convalescent plasma (1.4%). A total of 93.6% neonates were discharged home after care, 1.1% were transferred to another hospital, and discharge disposition was unknown for 5.2%. One neonate (0.1%) with presentation suggestive of multisystem inflammatory syndrome in children died after 11 days of hospitalization., Conclusions: Most neonates infected with SARS-CoV-2 were asymptomatic or developed mild illness without need for respiratory support. Some had severe illness requiring treatment of COVID-19 with remdesivir and COVID-19 convalescent plasma. SARS-CoV-2 infection in neonates, though rare, may result in severe disease.

Objective: The purpose of this report is to provide insight from pediatric stakeholders with a shared desire to facilitate a revision of the current United States regulatory pathways for the development of pediatric healthcare devices., Methods: On August 5, 2020, a group of innovators, engineers, professors and clinicians met to discuss challenges and opportunities for the development of new medical devices for pediatric health and the importance of creating a regulatory environment that encourages and accelerates the research and development of such devices. On January 6, 2021, this group joined regulatory experts at a follow-up meeting., Results: One of the primary issues identified was the need to present decision-makers with opportunities that change the return-on-investment balance between adult and pediatric devices to promote investment in pediatric devices., Discussion/conclusion: Several proposed strategies were discussed, and these strategies can be divided into two broad categories: 1. Removal of real and perceived barriers to pediatric device innovation; 2. Increasing incentives for pediatric device innovation.