Overview of the neonatal research network: History, contributions, challenges, and future

• Published in: Seminars in perinatology 2022-11, Vol.46 (7), p.151634-151634, Article 151634
• Main Authors: Watterberg, Kristi L, Carlo, Waldemar A, Brion, Luc P, Cotten, C. Michael, Higgins, Rosemary D
• Format: Article
• Language: English
• Subjects: BPCA, Best Pharmaceuticals for Children Act; BPD, Bronchopulmonary dysplasia; CDC, Centers for Disease Control and Prevention; Child; CPAP, Continuous positive airway pressure; ECMO, Extra-corporeal membrane oxygenation; FDA, U.S. Food and Drug Administration; Forecasting; GDB, Generic Database study; HEAL, Helping to End Addiction Long-term initiative; HIE, Hypoxic-ischemic encephalopathy; Humans; Infant, Newborn; iNO, Inhaled nitric oxide; ISPCTN, Idea States Pediatric Clinical Trials Network; MoCHA, Moderately Preterm Infants with Caffeine at Home for Apnea; National Institute of Child Health and Human Development (U.S.); NDI, Neurodevelopmental impairment; NEC, Necrotizing enterocolitis; NEI, National Eye Institute; Neonatal and Perinatal Medicine; NEST, Necrotizing Enterocolitis Surgery Trial; NHLBI, National Heart, Lung, and Blood Institute; NICHD, Eunice Kennedy Shriver National Institute of Child Health and Human Development; NICU, Neonatal intensive care unit; NIDA, National Institute for Drug Abuse; NIH, National Institutes of Health; NINDS, National Institute of Neurologic Disorders and Stroke; NINOS, Neonatal Inhaled Nitric Oxide Study; NRN, Neonatal Research Network; OHRP, Office for Human Research Protections; PGE1, Prostaglandin E1; RCT, Randomized controlled trial; ROP, Retinopathy of prematurity; SAVE, Randomized Trial of Minimal Ventilator Support and Early Corticosteroid Therapy to Increase Survival Without Chronic Lung Disease in Extremely-Low-Birth-Weight Infants; SIP, Spontaneous intestinal perforation; SUPPORT, Surfactant, Positive Pressure, and Oxygenation Randomized Trial; TOP, Transfusion of Prematures trial; United States
• ISSN: 0146-0005; 1558-075X; 1558-075X
• DOI: 10.1016/j.semperi.2022.151634

AbstractThe Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network (NRN) has been a leader in neonatal research since 1986. In this chapter we review its history and achievements in (1) continuing observation of populations, treatments, short and longer-term outcomes, and trends over time; (2) “negative studies” (trials with non-significant primary outcomes) and trials stopped for futility or adverse events, which have influenced practice and subsequent trial design; and, (3) landmark trials that have changed neonatal care. Its consistent framework has enabled the NRN to be a pioneer in conducting longer-term, school-age follow-up. Leveraging its established infrastructure, the NRN has also partnered with other NIH institutes, governmental agencies, and industry to more effectively advance neonatal care. As current examples of its evolution with changing times, the Network has instituted a process to open specific network trials to external institutions and is adding a parent and participant component to future endeavors.