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.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HD040492-14
Application #
8643279
Study Section
Special Emphasis Panel (ZHD1-DSR-A (03))
Program Officer
Raju, Tonse N
Project Start
2001-05-01
Project End
2016-03-31
Budget Start
2014-04-01
Budget End
2015-03-31
Support Year
14
Fiscal Year
2014
Total Cost
$299,518
Indirect Cost
$102,102
Name
Duke University
Department
Pediatrics
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
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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

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