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.
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.
|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|