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.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
Application #
Study Section
Special Emphasis Panel (ZHD1-DSR-A (03))
Program Officer
Higgins, Rosemary
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of Rochester
Schools of Dentistry
United States
Zip Code
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
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
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
Pedroza, Claudia; Tyson, Jon E; Das, Abhik et al. (2016) Advantages of Bayesian monitoring methods in deciding whether and when to stop a clinical trial: an example of a neonatal cooling trial. Trials 17:335
Foglia, Elizabeth E; Nolen, Tracy L; DeMauro, Sara B et al. (2015) Short-term Outcomes of Infants Enrolled in Randomized Clinical Trials vs Those Eligible but Not Enrolled. JAMA 313:2377-9
Stoll, Barbara J; Hansen, Nellie I; Bell, Edward F et al. (2015) Trends in Care Practices, Morbidity, and Mortality of Extremely Preterm Neonates, 1993-2012. JAMA 314:1039-51
Patel, Ravi M; Kandefer, Sarah; Walsh, Michele C et al. (2015) Causes and timing of death in extremely premature infants from 2000 through 2011. N Engl J Med 372:331-40
Tyson, Jon E; Walsh, Michele; D'Angio, Carl T (2014) Comparative effectiveness trials: generic misassumptions underlying the SUPPORT controversy. Pediatrics 134:651-4
Shankaran, Seetha; Laptook, Abbot R; Pappas, Athina et al. (2014) Effect of depth and duration of cooling on deaths in the NICU among neonates with hypoxic ischemic encephalopathy: a randomized clinical trial. JAMA 312:2629-39
Sood, Beena G; Keszler, Martin; Garg, Meena et al. (2014) Inhaled PGE1 in neonates with hypoxemic respiratory failure: two pilot feasibility randomized clinical trials. Trials 15:486

Showing the most recent 10 out of 14 publications