This application provides evidence that the Division of Neonatology and the Regional Neonatal Intensive Care Unit at the University of Alabama at Birmingham (UAB) have: 1) the multicenter 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. Since 1990, the Division has been involved in designing and implementing nine multicenter clinical trials. The eight board-certified neonatologists in the Division decidedly support collaborative research and this application. Approximately 1000 ill neonates per year are admitted to the Regional NICU at UAB, and the state- wide perinatal health care system and well-established referral patterns assure a large pool of admissions for clinical research in the coming years. Strong clinical ties and six current research projects with accomplished maternal-fetal medicine specialists foster an environment conducive to excellence in perinatal trials. Funded collaborations with over 20 established faculty members in 17 divisions, departments, and research centers throughout the University enable 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 the initial hospitalization and after discharge. A comprehensive, multidisciplinary Follow-Up Program that currently has 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. Around-the-clock availability of experienced research nurses allows patient enrollment and protocol implementation 24 hours a day, 7 days a week. A protocol concept, based on two large retrospective studies and substantial preliminary data in preterm infants, proposes a novel strategy for mechanical ventilation that may reduce the incidence of bronchopulmonary dysplasia. The proposed team of investigators at UAB will work with the NICHD and the Steering Committee to prioritize, plan, implement, analyze, interpret, and report a series of randomized 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 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 join the Neonatal Network as one of its clinical centers.
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