The primary goal of the University of Rochester (UR) - University at Buffalo (UB) Center in joining the Neonatal Research Network (NRN) is to improve the care of neonates through developing and participating in large, well-designed clinical trials that address important questions and include long-term follow-up.
The specific aims of this application to achieve this goal are: (1) To continue contributions to critical and creative thinking, generating new ideas for clinical trials;(2) To participate fully in NRN trials by enrolling and retaining as many subjects as possible in a safe and ethical manner;and (3) To achieve a high follow-up rate, as this is critical to testing therapies in the neonate. To realize these aims, UR and UB have developed a single center (URUB) with two performance sites. URUB provides a strong academic faculty with a long-standing commitment to clinical trial excellence, large neonatal populations with high rates of recruitment and retention, excellent University and hospital support, experienced clinical research staff, established neonatal neurodevelopmental follow-up clinics, well- developed data systems, high-quality maternal-fetal medicine services, and strong obstetrical-neonatal communication. Dr. Carl D'Angio, the URUB PI, is a leading investigator in premature infant vaccine responses and has led NRN vaccine studies. Dr. D'Angio is PI of the Premature Infant Vaccine Collaborative, a multicenter group devoted to investigating vaccines in premature infants, of which UB is a collaborating center. Dr. Rita Ryan, the URUB Alternate PI, is one of the PIs for a large joint center grant awarded to URUB, the Prematurity Respiratory Outcomes Program (PROP), involving both basic scientists and clinical investigators. The faculty at the URUB Center has an impressive history of intellectual leadership in NIH-funded clinical research. The URUB Center specifically brings together two geographically-adjacent neonatal populations to enhance subject availability for Network Studies. Both sites have strong, existing neonatal follow-up programs with excellent follow-up rates, which are critical to our full participation and optimal contributions to the Neonatal Research Network.

Public Health Relevance

The Neonatal Research Network is an excellent platform for conceiving and completing large, well-designed clinical trials, with recent randomized clinical trials in the areas of neuroprotection, hyperbilirubinemia, inhaled nitric oxide, and supplemental oxygen and respiratory management. The URUB Clinical Center has the leadership, enrollment and follow-up capabilities to be an excellent venue for future, similar successes.

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 #
1U10HD068263-01
Application #
8081325
Study Section
Special Emphasis Panel (ZHD1-DSR-A (03))
Program Officer
Higgins, Rosemary
Project Start
2011-04-01
Project End
2016-03-31
Budget Start
2011-04-01
Budget End
2012-03-31
Support Year
1
Fiscal Year
2011
Total Cost
$286,540
Indirect Cost
Name
University of Rochester
Department
Pediatrics
Type
Schools of Dentistry
DUNS #
041294109
City
Rochester
State
NY
Country
United States
Zip Code
14627
James, Jennifer; Munson, David; DeMauro, Sara B et al. (2017) Outcomes of Preterm Infants following Discussions about Withdrawal or Withholding of Life Support. J Pediatr 190:118-123.e4
D'Angio, C T; Wang, H; Hunn, J E et al. (2017) Permission form synopses to improve parents' understanding of research: a randomized trial. J Perinatol 37:735-739
Watterberg, K L; Fernandez, E; Walsh, M C et al. (2017) Barriers to enrollment in a randomized controlled trial of hydrocortisone for cardiovascular insufficiency in term and late preterm newborn infants. J Perinatol 37:1220-1223
Peralta-Carcelen, Myriam; Carlo, Waldemar A; Pappas, Athina et al. (2017) Behavioral Problems and Socioemotional Competence at 18 to 22 Months of Extremely Premature Children. Pediatrics 139:
Younge, Noelle; Goldstein, Ricki F; Bann, Carla M et al. (2017) Survival and Neurodevelopmental Outcomes among Periviable Infants. N Engl J Med 376:617-628
Puopolo, Karen M; Mukhopadhyay, Sagori; Hansen, Nellie I et al. (2017) Identification of Extremely Premature Infants at Low Risk for Early-Onset Sepsis. Pediatrics 140:
D'Angio, Carl T; Ambalavanan, Namasivayam; Carlo, Waldemar A et al. (2016) Blood Cytokine Profiles Associated with Distinct Patterns of Bronchopulmonary Dysplasia among Extremely Low Birth Weight Infants. J Pediatr 174:45-51.e5
Archer, Stephanie Wilson; Carlo, Waldemar A; Truog, William E et al. (2016) Improving publication rates in a collaborative clinical trials research network. Semin Perinatol 40:410-417
Meyers, J M; Bann, C M; Stoll, B J et al. (2016) Neurodevelopmental outcomes in postnatal growth-restricted preterm infants with postnatal head-sparing. J Perinatol 36:1116-1121
Boghossian, Nansi S; Hansen, Nellie I; Bell, Edward F et al. (2016) Outcomes of Extremely Preterm Infants Born to Insulin-Dependent Diabetic Mothers. Pediatrics 137:

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