Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network

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DESCRIPTION (provided by applicant): 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.