North Carolina Clinical Center

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Abstract The Duke University Division of Neonatology enthusiastically submits this renewal application for participation in the Eunice Kennedy Shriver NICHD-sponsored Cooperative Multicenter Neonatal Research Network (NRN). Duke is submitting the application in collaboration with the University of North Carolina at Chapel Hill (UNC) and East Carolina University (ECU), as the North Carolina Clinical Center (NCCC) for the NRN. To support the NRN Duke's and the NCCC's aims are to: 1) enroll demographically diverse patients in NRN studies and achieve high follow-up rates, 2) develop innovative trial designs and concepts for NRN studies, and 3) develop the next generation of clinical research leaders in Neonatology via interactions with the NRN. In support of the 3 aims Duke has added satellite sites to increase eligible patient populations and broaden opportunities for NRN interactions. Duke was the first NRN site to add an independent academic institution when the UNC joined Duke in 2008. ECU, located in Greenville, NC, joined in 2018. The NCCC has been among the top 5 enrolling sites among recently completed and currently enrolling NRN trials. Follow-up for over 250 infants enrolled in clinical trials has been over 95%. Follow-up for infants in the NRN observational trials is 86%, slightly above the NRN overall rate of 84%. The NCCC UNC site PI leads the NRN PDA trial. In the last cycle, over 20 NCCC investigators co-authored 52 NRN publications, including 9 first-author papers. NCCC sites will continue maximizing enrollment efforts and maintain high follow-up rates for NRN studies. The NCCC leadership will provide significant clinical trial experience to the NRN, and will bring innovative concepts such as a Global Rank Score for composite outcomes and new study designs such as master protocols to promote efficient conduct of and comparisons between trials. We will initiate a Protocol Incubator system to support protocol development by early career investigators. In addition, we will bring concepts for studies to validate new technology, including testing of optical coherence tomography for retinal imaging and associations with visual acuity and neurodevelopmental outcomes. Duke, UNC, and ECU fully support the NCCC's ongoing collaborative commitment to the NRN. We firmly believe that our NRN interactions have improved care of infants in our three institutions, and throughout our State. We are highly motivated to improve outcomes of infants, and support development of the next generation of clinician scientists in Neonatology, by working with the NRN.