The Duke University School of Medicine, Division of Neonatology enthusiastically submits this renewal application for a third consecutive cycle of participation in the Eunice Kennedy Shriver NlCHD-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, with the goal of achieving improved medical and neurodevelopmental outcomes.
Our aims at Duke are to: 1) prioritize and conduct approved NRN protocols while maintaining a >90% follow-up rate;2) foster development of trainees and collaborations with investigators from multiple disciplines to advance the care of neonates;3) bring innovative, cutting-edge research opportunities to the NRN. In support of these aims we added the University of North Carolina at Chapel Hill (UNC) as a satellite site in January 2009. The addition of UNC doubles the study population and enhances our clinical trial expertise. We are the only current NRN site participating in all three current NRN pilot studies, and enrolled the 3'^ highest number of infants in the 2009 Generic Data Base. We maintain multidisciplinary follow-up clinics with follow-up rates for clinical trials >90%. We participate in nine active NRN subcommittees, and lead two major Network projects that combine institutional expertise in Infectious Diseases, Medical Mycology, Biomedical Engineering, and Genetic Epidemiology, namely, Early Diagnosis of Neonatal Candidiasis and the NICHD NRN Anonymized DNA Bank. In 2010 we and investigators from 5 NRN sites are using the DNA bank to complete a genome wide scan and 7 candidate gene analyses for common morbidities of extremely low birthweight infants. We have authored or co-authored 16 NRN publications in the last cycle. We prioritize involvement of junior faculty in the NRN as attested by their concept and study applications and participation in subcommittees. At PAS in 2010 young investigators from Duke and two other NRN sites presented secondary analyses of the Candidiasis study. Duke and UNC are Clinical and Translational Science Award (CTSA) sites. CTSA directly supports our NRN work and adds further opportunity for innovation.

Public Health Relevance

The Neonatal Research Network's high impact research requires active sites with innovative ideas. The Duke-UNC site provides a large and diverse patient population for Network studies and adds a very strong record of working with Network collaborators to 1) develop innovative, multidisciplinary approaches to health problems of newborn infants, and 2) foster early career development of young clinician scientists who will have significant impact on the care of newborns.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HD040492-13
Application #
8449145
Study Section
Special Emphasis Panel (ZHD1-DSR-A (03))
Program Officer
Raju, Tonse N
Project Start
2001-05-01
Project End
2016-03-31
Budget Start
2013-04-01
Budget End
2014-03-31
Support Year
13
Fiscal Year
2013
Total Cost
$292,454
Indirect Cost
$108,299
Name
Duke University
Department
Pediatrics
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Natarajan, Girija; Shankaran, Seetha; Saha, Shampa et al. (2018) Antecedents and Outcomes of Abnormal Cranial Imaging in Moderately Preterm Infants. J Pediatr 195:66-72.e3
Autmizguine, Julie; Tan, Sylvia; Cohen-Wolkowiez, Michael et al. (2018) Antifungal Susceptibility and Clinical Outcome in Neonatal Candidiasis. Pediatr Infect Dis J 37:923-929
Jilling, Tamas; Ambalavanan, Namasivayam; Cotten, C Michael et al. (2018) Surgical necrotizing enterocolitis in extremely premature neonates is associated with genetic variations in an intergenic region of chromosome 8. Pediatr Res 83:943-953
Bajaj, Monika; Natarajan, Girija; Shankaran, Seetha et al. (2018) Delivery Room Resuscitation and Short-Term Outcomes in Moderately Preterm Infants. J Pediatr 195:33-38.e2
Natarajan, Girija; Shankaran, Seetha; Laptook, Abbot R et al. (2018) Association between sedation-analgesia and neurodevelopment outcomes in neonatal hypoxic-ischemic encephalopathy. J Perinatol 38:1060-1067
Gray, Keyaria D; Dudash, Kathryn; Escobar, Carla et al. (2018) Prevalence and safety of diazoxide in the neonatal intensive care unit. J Perinatol 38:1496-1502
Hintz, Susan R; Vohr, Betty R; Bann, Carla M et al. (2018) Preterm Neuroimaging and School-Age Cognitive Outcomes. Pediatrics 142:
Kumar, Karan R; Clark, David A; Kim, Evan M et al. (2018) Association of Atrial Septal Defects and Bronchopulmonary Dysplasia in Premature Infants. J Pediatr 202:56-62.e2
Vohr, Betty R; Heyne, Roy; Bann, Carla M et al. (2018) Extreme Preterm Infant Rates of Overweight and Obesity at School Age in the SUPPORT Neuroimaging and Neurodevelopmental Outcomes Cohort. J Pediatr 200:132-139.e3
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201

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