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Principal Investigator: CHARLES Michael COTTEN
Organization: DUKE UNIVERSITY
Fiscal Year: 2024
Award: $352,458
Funding agency: Eunice Kennedy Shriver National Institute of Child Health and Human Development
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.
Terms: <0-4 weeks old><Actinotherapy><Active Follow-up><Active Sites><African American><Afro American><Afroamerican><Candidiasis><Candidosis><Childhood><Chiro-Inositol><Classification><Clinical><Clinical Research><Clinical Study><Clinical Trials><Clinical Trials Design><Collaborations><Common Data Element><Communities><DNA Library><DNA bank><Data Bases><Databases><Development><Doppler OCT><Eligibility><Eligibility Determination><Enrollment><Faculty><Follow-Up Studies><Followup Studies><Fostering><Health><Hispanic><Incubators><Infant><Infant Care><Infant Health><Inositol><Institution><Investigators><Journals><Lead><Leadership><Light Therapy><Link><Low Birth Weight Infant><Magazine><Manuscripts><Maternal Health><Medical center><Mesoinositol><Mission><Moniliasis><Multi-center Neonatal Research Network><Multi-center trial><Multicenter Neonatal Research Network><Multicenter Trials><NICHD><National Institute of Child Health and Human Development><National Institute of Children's Health and Human Development><Neonatal Research Network><Neonatology><Neurodevelopmental Impairment><Newborn Infant><Newborns><Non-Hispanic><Nonhispanic><North Carolina><Not Hispanic or Latino><OCT Tomography><Observation research><Observation study><Observational Study><Observational research><Optical Coherence Tomography><Outcome><Outcome Assessment><Paper><Patients><Pb element><Perinatal><Peripartum><Phase><Photoradiation Therapy><Phototherapy><Population Heterogeneity><Premature Infant><Process><Protocol><Protocol Screening><Protocols documentation><Psychologist><Publications><Reporting><Research><Research Design><Research Personnel><Research Resources><Researchers><Resources><Review Committee><Scientific Publication><Scientist><Self-Help Groups><Site><Staff Development><Study Type><Support Groups><System><Systematics><Testing><Transfusion><Universities><Update><Visual Acuity><Vital Statistics><active followup><baby care><career><career development><clinical center><clinical practice><clinical research site><clinical site><collaborative approach><community engaged participatory research><community engaged research><community partnered research><community-engaged study><community-partnered study><data base><death risk><design><designing><developmental><diverse populations><enroll><environment enrichment><environment enrichment for laboratory animals><environmental enrichment><environmental enrichment for laboratory animals><experience><follow up><follow-up><followed up><followup><health equity><heavy metal Pb><heavy metal lead><heterogeneous population><high risk><imaging biomarker><imaging marker><imaging-based biological marker><imaging-based biomarker><imaging-based marker><improved><improved outcome><infant health care><infant healthcare><infant outcome><infants born premature><infants born prematurely><innovate><innovation><innovative><interdisciplinary approach><light intervention><light treatment><low birth weight><low birthweight><mortality risk><multidisciplinary approach><neuroimaging biomarker><neuroimaging marker><new technology><newborn care><newborn child><newborn children><next generation><novel><novel technologies><operation><operations><optical Doppler tomography><optical coherence Doppler tomography><participant enrollment><patient enrollment><patient population><pediatric><perinatal services><population diversity><premature><premature baby><premature infant human><prematurity><preterm baby><preterm infant><preterm infant human><protocol development><retina imaging><retinal imaging><self help organization><study design><trial design>