This competing renewal application aims to demonstrate that the Floating Hospital for Children at Tufts Medical Center has the patient population, faculty and staff expertise, clinical services, research resources, and enrollment and follow-up successes to continue as an outstanding and productive member of the NICHD's Neonatal Research Network (NRN). Tufts has a long history of leadership in collaborative multicenter clinical research studies, as exemplified by one of the highest track records in the NRN for both enrollment (55%) and follow-up (97%) in the recently completed SUPPORT trial. Tufts draws upon an ethnically and geographically diverse neonatal population that receives its care in one of the largest level III nurseries in Boston. Approximately 600 infants (70% inborn) are admitted annually to its 41-bed NICU. In addition, both the Newborn Medicine and Maternal-Fetal Medicine programs have well-established affiliations with regional hospitals that result in referrals from a catchment area of 19,000 annual births. The Principal Investigator, Dr. Ivan D. Frantz III, and the Division of Newborn Medicine's faculty, have shown that they have the organizational strengths and research experience to design, implement, and actively participate in clinical trials. Our application is enhanced by an innovative concept application that incorporates a noninvasive genomic approach to explain the mechanisms underlying clinical variability in newborn infants of similar gestational ages and environmental exposures through analysis of salivary RNA. The Tufts program has broad institutional support and outstanding resources for the conduct of clinical research, data management and safety monitoring. Furthermore, the recent development of a Clinical Translational Science Institute (CTSI) at Tufts University and a Mother Infant Research Institute at Tufts Medical Center provide both infrastructure and additional collaborations.
Through participation in multicenter studies, we will discover new approaches to care of high-risk infants that will result in decreased morbidity and mortality in this population. Such improvements will ultimately result in decreased expenditures for care and a decrease in the burden of disease both for individual patients and society.
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