This application provides evidence that the Division of Neonatology and the Regional Neonatal Intensive Care Unit (NICU) at the University of Alabama at Birmingham (UAB) have: 1) the clinical trial experience, 2) the qualified and motivated professional personnel, 3) a large and high- risk patient population, 4) all-inclusive facilities and resources, and 5) the broad University and medical community support to meet and exceed each of the requirements of the NICHD Cooperative Neonatal Research Network Request for Application. In addition to the active participation in the NICHD Neonatal Network studies, the Division has been involved in the design and implementation of ten multicenter and six single center randomized clinical trials during the last decade. The eight board- certified neonatologists in the Division decidedly support collaborative research and this application. An average of 945 neonates are admitted per year to the Regional NICU at UAB. The well established referral patterns from all NICUs in the region and the state-wide perinatal health care system assure a large pool of high-risk admissions for clinical research in the coming years. Strong clinical ties and ongoing collaborative clinical research projects and grants with accomplished maternal-fetal medicine specialists foster an environment conducive to excellence in perinatal trials. Collaboration with over 20 established faculty members in 12 divisions, departments, and research centers throughout the University support exceptional research. State-of-the-art facilities, talented personnel, and full clinical capabilities allow the Division to provide services for neonates with any medical or surgical disorder during hospitalization and after discharge. The comprehensive, multidisciplinary follow-up program with over 90% compliance rate assures thorough long-term evaluation and care. Existing complementary maternal and infant data bases maintained by dedicated personnel are routinely used for data retrieval, analysis, and research. Availability of three full-time experienced neonatal research nurses allows patient enrollment and protocol implementation 24 hours a day, 7 days a week. A protocol concept, based on large retrospective studies in preterm infants and randomized studies in preterm infants and adults, proposes a novel strategy for mechanical ventilation that may reduce the incidence and severity of chronic lung disease. The proposed team of investigators at UAB will work with the NICHD and the Steering Committee to design, prioritize, plan, implement, analyze, interpret, and report randomized trials and observational studies to address and resolve current and future controversies in neonatal care. The investigators believe that strict adherence to rigorously designed studies is necessary to identify optimal diagnostic, therapeutic, and management strategies. They fully support the philosophy, purpose, policies, and procedures of the Neonatal Network. The qualifications and unequivocal commitment of the Principal Investigator, Division, Department, and University will ensure superior performance if UAB is selected to continue in the Neonatal Network.
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