Archiving and Documenting Data from the NICHD Neonatal Research Network

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Project Summary The Neonatal Research Network (NRN) was established by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in 1993 to facilitate the advancement of neonatal care by establishing a network of academic centers that, by rigorous investigation of the safety and efficacy of treatment strategies for newborn infants, can meaningfully enhance the evidence base for neonatal medicine. The Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure (Preemie iNO) Trial, the Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia (Benchmarking Trial), and the Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) are three studies involving respiratory management strategies and outcomes for extremely premature/low birthweight neonates conducted by the NRN before the NICHD Data and Specimen Hub (N-DASH) became available (2000-2009). The Preemie iNO trial tested whether inhaled nitric oxide reduces death or bronchopulmonary dysplasia (BPD) in low birth weight (401-1500 g) infants less than 34 weeks gestational age with severe lung disease. The Benchmarking trial tested whether Neonatal Intensive Care Unit teams trained in benchmarking—comparing care practices between different NICUs to see which practices prevent BPD—and quality improvement would change practices and improve rates of survival without BPD in inborn neonates with birth weights <1250 g. SUPPORT compared continuous positive airway pressure initiated at birth with early administration of surfactant for infants born at 24 to 27 weeks gestation to determine the effect on BPD and survival of premature infants. The results of all these studies have been published, but comprehensive datasets and documentation are not available in any publicly accessible data repository. Meanwhile, these data remain highly valuable to researchers, particularly given that despite measurable improvements in neonatal care over the past 30 years, BPD rates have not improved for extremely premature babies and few efficacious preventive therapies exist. However, because these studies were completed prior to the existence of N-DASH, they are not available in a public repository that would make them proactively available to researchers to spark new investigations. Therefore, RTI International proposes to use our institutional knowledge of the NRN and our DCC infrastructure to achieve the following specific aims in response to PAR-16-149 Archiving and Documenting Child Health and Human Development Data Sets (R03): (1) create public use datasets and documentation for the Preemie iNO, Benchmarking, and SUPPORT trials; (2) harmonize the data to facilitate analyses that make use of data from multiple studies; and (3) share the public use datasets and documentation through N-DASH.