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 fourth consecutive cycle of participation in the Eunice Kennedy Shriver NICHD-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, that lead to improved medical and neurodevelopmental outcomes. Duke's aims in support of the NRN are to: 1) prioritize and conduct approved NRN protocols while maintaining a > 90% follow-up rate; 2) bring innovative, collaborative multidisciplinary research opportunities to the NRN; 3) introduce young faculty to NRN mentoring opportunities to foster new ideas and ensure ongoing progress in Neonatal Intensive Care. In support of these aims Duke added two satellite sites. In January 2009, Duke was the first Network site to add an independent academic institution when the University of North Carolina at Chapel Hill (UNC) joined Duke. WakeMed Medical Center was added in July 2014. The addition of UNC and WakeMed expands the study population and enhances the Site's clinical trial expertise. It also increases the impact of NRN studies on neonatal health care in our region and State. The Duke Site (Duke, UNC, WakeMed) leads enrollment in the NRN Inositol phase III trial and is among the highest enrolling sites in th Network's Generic Database and Transfusion for Prematures studies. Duke, UNC, and WakeMed maintain multidisciplinary follow-up clinics which maintain follow-up rates for clinical trials and cohort studies > 90%. Duke leads two major Network projects, "Early Diagnosis of Neonatal Candidiasis" and the "Anonymized DNA Bank", that combined Duke' expertise in Infectious Diseases, Medical Mycology, Biomedical Engineering, Genetic Epidemiology and Molecular Methodologies. Candida trial materials continue to be analyzed and have provided information that has likely contributed to the decrease in Candidiasis. The DNA bank samples and linked clinical data have been used to identify associations between variants in phosphorylase pathway genes and BPD risk, and variants in the BDNF gene and severe retinopathy. This year at PAS NRN investigators reported associations between variants in an intragenic region on chromosome 8 and severe NEC that reached genome wide significance. The Bank's data has also been used as a validation cohort for other NIH-funded investigations of genetic associations with morbidities of prematurity. In addition to these two studies which have produced resources still being used by investigators from multiple sites, Duke has made involvement of junior faculty and trainees in the NRN. Eight different Duke Site investigators have co-authored 38 NRN papers published in the last cycle (8 first-author papers). Duke, UNC, and WakeMed will continue efforts to maximize enrollment and maintain follow-up for cohort studies and clinical trials > 90%. Innovative studies of cell therapy for brain injury and management strategies for Patent Ductus Arteriosus (PDA trial) have been reviewed by the NRN and are likely to begin in the 2016 - 2021 cycle. The PDA protocol is led by Dr. Laughton (UNC). The autologous cord blood study for infants with neonatal encephalopathy (Cotten) was presented as an NRN concept in January 2015, and approved to be developed into a full protocol for NRN consideration. The Duke Site will continue these efforts plus bring additional novel concepts for clinical trials. The Duke, UNC, and WakeMed Departments of Pediatrics, and the Health Systems fully support our ongoing collaborative commitment to the NRN, as we firmly believe that our interactions with the NRN have directly affected and improved the care of infants in our three institutions and throughout our State.