North Carolina Clinical Center

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.