NICHD Cooperative Multicenter Neonatal Research Network

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DESCRIPTION (provided by applicant): The Division of Newborn Medicine at the Floating Hospital for Children at Tufts-New England Medical Center (Tufts-NEMC), Tufts University School of Medicine, Boston, is submitting a new application for participation in the NICHD Neonatal Research Network (NRN). This application demonstrates that the Floating Hospital meets and exceeds the criteria for NRN sites as outlined in the RFA. The Floating Hospital's Division of Newborn Medicine has a long history of leadership in multicenter clinical trials, with a superb record for enrollment and follow-up. Members of the Division have been involved in 24 multicenter clinical studies in the past fifteen years. The Principal Investigator, Ivan D. Frantz, III has extensive experience both in design of multicenter trials of his own, as well as participation in those of others. The Division has exceptionally strong research partnerships with Tufts-NEMC's Divisions of Maternal-Fetal Medicine and Genetics. More than 600 infants from a diverse population are admitted annually to the Floating Hospital's 41 bed level III neonatal ICU. Newborn Medicine and Maternal-Fetal Medicine have well-established formal affiliations with hospitals in the area with 19,000 annual births, ensuring a consistent patient base for clinical and translational research. NICU and antepartum support staff have extensive experience with clinical investigation. A full spectrum of multidisciplinary follow-up services for high-risk NICU graduates is provided at The Floating Hospital's Neonatal Follow-Up Clinic. The Division enjoys broad institutional support for clinical research, and the environment offers extraordinary resources for conduct of research, data management, and safety monitoring, including the Tufts-NEMC General Clinical Research Center, which has supported many of the Division's studies. The Division's expertise and judgment in study selection and design is demonstrated by inclusion of an important, innovative and soundly designed concept application. The Floating Hospital's strong clinical services, diverse and stable patient population, experience and leadership in collaborative clinical research, outstanding resources, and strong commitment will be enormous assets to the NRN. This application represents a unique opportunity to strengthen the NICHD Neonatal Research Network through addition of the diverse resources and areas of expertise at the Floating Hospital, thereby advancing our common goal of reducing infant morbidity and mortality.