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)
Project #
Application #
Study Section
Special Emphasis Panel (ZHD1-DSR-A (03))
Program Officer
Raju, Tonse N
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Duke University
Schools of Medicine
United States
Zip Code
Ambalavanan, Namasivayam; Cotten, C Michael; Page, Grier P et al. (2015) Integrated genomic analyses in bronchopulmonary dysplasia. J Pediatr 166:531-7.e13
Davis, A S; Gantz, M G; Do, B et al. (2015) Serial aEEG recordings in a cohort of extremely preterm infants: feasibility and safety. J Perinatol 35:373-8
Randolph, David A; Nolen, Tracy L; Ambalavanan, Namasivayam et al. (2014) Outcomes of extremely low birthweight infants with acidosis at birth. Arch Dis Child Fetal Neonatal Ed 99:F263-8
Cotten, C Michael; Goldstein, Ricki F; McDonald, Scott A et al. (2014) Apolipoprotein E genotype and outcome in infants with hypoxic-ischemic encephalopathy. Pediatr Res 75:424-30
Fernandez, Erika; Watterberg, Kristi L; Faix, Roger G et al. (2014) Incidence, management, and outcomes of cardiovascular insufficiency in critically ill term and late preterm newborn infants. Am J Perinatol 31:947-56
Wadhawan, R; Oh, W; Hintz, S R et al. (2014) Neurodevelopmental outcomes of extremely low birth weight infants with spontaneous intestinal perforation or surgical necrotizing enterocolitis. J Perinatol 34:64-70
Hartnett, M Elizabeth; Morrison, Margaux A; Smith, Silvia et al. (2014) Genetic variants associated with severe retinopathy of prematurity in extremely low birth weight infants. Invest Ophthalmol Vis Sci 55:6194-203
DeMauro, Sara B; D'Agostino, Jo Ann; Bann, Carla et al. (2014) Developmental outcomes of very preterm infants with tracheostomies. J Pediatr 164:1303-10.e2
Davis, A S; Hintz, S R; Goldstein, R F et al. (2014) Outcomes of extremely preterm infants following severe intracranial hemorrhage. J Perinatol 34:203-8
Shankaran, Seetha; Laptook, Abbot R; Pappas, Athina et al. (2014) Effect of depth and duration of cooling on deaths in the NICU among neonates with hypoxic ischemic encephalopathy: a randomized clinical trial. JAMA 312:2629-39

Showing the most recent 10 out of 81 publications