The Duke University School of Medicine, Division of Neonatology enthusiastically submits this renewal application for a third consecutive cycle of participation in the Eunice Kennedy Shriver NlCHD-sponsored Cooperative Multicenter Neonatal Research Network (NRN). The NRN's purpose is to perform interventional and observational clinical studies in newborn infants, particularly those of low birth weight or gestation, with the goal of achieving improved medical and neurodevelopmental outcomes.
Our aims at Duke are to: 1) prioritize and conduct approved NRN protocols while maintaining a >90% follow-up rate;2) foster development of trainees and collaborations with investigators from multiple disciplines to advance the care of neonates;3) bring innovative, cutting-edge research opportunities to the NRN. In support of these aims we added the University of North Carolina at Chapel Hill (UNC) as a satellite site in January 2009. The addition of UNC doubles the study population and enhances our clinical trial expertise. We are the only current NRN site participating in all three current NRN pilot studies, and enrolled the 3'^ highest number of infants in the 2009 Generic Data Base. We maintain multidisciplinary follow-up clinics with follow-up rates for clinical trials >90%. We participate in nine active NRN subcommittees, and lead two major Network projects that combine institutional expertise in Infectious Diseases, Medical Mycology, Biomedical Engineering, and Genetic Epidemiology, namely, Early Diagnosis of Neonatal Candidiasis and the NICHD NRN Anonymized DNA Bank. In 2010 we and investigators from 5 NRN sites are using the DNA bank to complete a genome wide scan and 7 candidate gene analyses for common morbidities of extremely low birthweight infants. We have authored or co-authored 16 NRN publications in the last cycle. We prioritize involvement of junior faculty in the NRN as attested by their concept and study applications and participation in subcommittees. At PAS in 2010 young investigators from Duke and two other NRN sites presented secondary analyses of the Candidiasis study. Duke and UNC are Clinical and Translational Science Award (CTSA) sites. CTSA directly supports our NRN work and adds further opportunity for innovation.

Public Health Relevance

The Neonatal Research Network's high impact research requires active sites with innovative ideas. The Duke-UNC site provides a large and diverse patient population for Network studies and adds a very strong record of working with Network collaborators to 1) develop innovative, multidisciplinary approaches to health problems of newborn infants, and 2) foster early career development of young clinician scientists who will have significant impact on the care of newborns.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Special Emphasis Panel (ZHD1-DSR-A (03))
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Higgins, Rosemary
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Duke University
Schools of Medicine
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Cotten, Charles M (2016) Adverse consequences of neonatal antibiotic exposure. Curr Opin Pediatr 28:141-9
Younge, Noelle; Smith, P Brian; Gustafson, Kathryn E et al. (2016) Improved survival and neurodevelopmental outcomes among extremely premature infants born near the limit of viability. Early Hum Dev 95:5-8
Thakkar, N; Gonzalez, D; Cohen-Wolkowiez, M et al. (2016) An opportunistic study evaluating pharmacokinetics of sildenafil for the treatment of pulmonary hypertension in infants. J Perinatol 36:744-7
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Phelps, Dale L; Ward, Robert M; Williams, Rick L et al. (2016) Safety and pharmacokinetics of multiple dose myo-inositol in preterm infants. Pediatr Res 80:209-17
Riccio, Daniel A; Malowitz, Jonathan R; Cotten, C Michael et al. (2016) S-Nitrosylated fetal hemoglobin in neonatal human blood. Biochem Biophys Res Commun 473:1084-9
Meyers, J M; Bann, C M; Stoll, B J et al. (2016) Neurodevelopmental outcomes in postnatal growth-restricted preterm infants with postnatal head-sparing. J Perinatol 36:1116-1121
Archer, Stephanie Wilson; Carlo, Waldemar A; Truog, William E et al. (2016) Improving publication rates in a collaborative clinical trials research network. Semin Perinatol 40:410-417

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