Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network

NIH RePORTER · NIH · UG1 · $278,783 · view on reporter.nih.gov ↗

Abstract

 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...

Key facts

NIH application ID
10348104
Project number
5UG1HD040492-21
Recipient
DUKE UNIVERSITY
Principal Investigator
CHARLES Michael COTTEN
Activity code
UG1
Funding institute
NIH
Fiscal year
2021
Award amount
$278,783
Award type
5
Project period
2001-05-01 → 2023-03-31