This application provides evidence that the clinical center at the University of Alabama at Birmingham (UAB) meets and exceeds each of the requirements of the NICHD Cooperative Multicenter Neonatal Research Network (NRN) Request for Applications. Major strengths of this clinical center include: 1) UAB has had the highest or second highest patient enrollment in 12 of 13 randomized controlled trials completed during the last three five-year cycles of the NRN as well as the highest number of infants followed at 18-22 months and the second highest number of Generic Data Base infants during the current cycle, 2) the UAB PI has been a leader in the NRN, being PI of three major innovative studies (SAVE Factorial Trial, Cytokine, SUPPORT Factorial Oxygenation Trial, one each during the three cycles), chair of the Publication Subcommittee, and a collegial steering committee member who fosters rigorous research and collaboration, 3) Division of Neonatology members are committed to the NRN with four investigators at UAB having been senior or first authors of 12 peer-reviewed, published manuscripts during the current NRN cycle and three other members have pending first author publications, 4) strong clinical ties and ongoing collaborative clinical research projects and grants with accomplished maternal-fetal medicine specialists and a top performing NICU/MFMU clinical center that foster an environment conducive to excellence in perinatal trials, 5) a well established referral pattern that includes all NlCUs in the state and the statewide perinatal health care system which assures a large pool of high-risk admissions for clinical research in the coming years, 6) and a comprehensive, multidisciplinary High-Risk Newborn Follow-Up Program with over 90% compliance rate that assures long-term evaluation and care. An innovative protocol concept based on clinical studies and randomized trials in infants that indicate a high likelihood for a large beneficial effect proposes a placebo- controlled randomized trial of combined immune modifying therapy in infants with late onset sepsis that may reduce mortality and morbidity.
The relevance of the application is that UAB's participation in rigorously designed studies will identify diagnostic, therapeutic, and management strategies to reduce mortality and morbidities in neonates. The innovative combined immunomodulating protocol proposes aims to reduce mortality and morbidity for neonates with late onset sepsis, one of the major causes of death and permanent handicap in newborns.
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