The primary goal of the combined University of Rochester (UR) - University at Buffalo (UB) Center's participation in the Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network (NRN) is to improve the care of neonates through conceiving, developing, participating in, and completing large, well-designed interventional and observational trials that address important clinical questions.
The specific aims of this application to continue to achieve this goal are: 1. To continue contributions to critical and creative thinking, generating new ideas for clinical trials and their conduct; 2. To continue 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 level of follow-up, as this is critical to our testing of therapies in the neonate. To realize these aims, UR and UB will continue to participate as a combined Clinical Center with two performance sites (URUB). URUB provides proven enrollment, management and intellectual capabilities in the setting of strong academic clinical and basic science faculties with long-standing commitments 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. The URUB Center includes two geographically-adjacent NICUs, each with large neonatal populations, to increase subject availability, and draws on the intellectual excellence of two respected academic neonatal divisions. Center investigators have conceived and led several major NRN studies and contribute to every aspect of NRN planning and governance. The Center has consistently ranked in the top 35% of NRN centers for number of infants enrolled in clinical trials, and ranks 5th in size, as measured by enrollment in the generic database (GBD) of infants <29 weeks' gestation. URUB has achieved 100% follow- up of infants enrolled in NRN randomized controlled trials. This innovative application also contains proposals improve investigator training and to increase further the Center's capacity. The URUB Center has a strong record of involving young investigators in NRN activities. URUB will advance this effort by providing multi-faceted, formalized training for young investigators, to enable them to become the next generation of leaders in neonatal trials. The Center is also poised, if this application is successful, to expand the Center across upstate NY with the potential addition of Albany Medical Center. The intellectual, organizational and operational strengths detailed in this proposal will allow the URUB Clinical Center to continue to participate at the highest level in all aspects of the work of the NRN.
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 brain protection and lung disease in premature infants. The URUB Clinical Center has the leadership, enrollment and follow-up capabilities to continue to be an excellent venue for future, similar successes.
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