The primary goal of the combined University of Rochester (UR) – University at Buffalo (UB) Center’s participation in the Eunice Kennedy Shriver NICHD 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 are: 1. To continue to participate fully in NRN trials by recruiting, retaining, and following a diverse population of infants in a safe and ethical manner; 2. To afford novel opportunities for neonatal research by sharing our resources and expertise in diverse areas of investigation, and by generating and leading new clinical trials; and 3. To lead the NRN in adapting to a new era of wider external investigator participation and enhanced rigor in the evaluation of potential trials. To realize these aims, UR and UB will continue to participate as a combined Clinical Center with two performance sites (URUB), an arrangement that has been effective and efficient for over a decade. 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. The Center has consistently ranked in the first or second quartile of NRN centers for number of infants enrolled in clinical trials, and ranks 6th in size, as measured by enrollment in the generic database (GBD) of infants <29 weeks’ gestation. With an eye to the future, the Center has already been instrumental in planning to accomplish NICHD’s stated goals of enhancing rigor and reproducibility through NIH peer review of all new protocols, promoting greater availability of multisite clinical trial infrastructure to support trials from a wider range of investigators through a more open, inclusive mechanism for study proposals, facilitating data sharing and access to biospecimens through timely deposit of data and biospecimens into the NICHD Data and Specimen Hub (DASH) and similar repositories, and facilitating greater involvement of diverse populations in multisite clinical trials through continued enrollment of racially, socially and economically diverse participants. The URUB Center’s intellectual, organizational and operational strengths will allow it to lead and participate substantially as the NRN ex...