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 qualified and motivated professional personnel, 2) the proficiency in clinical trials, 3) a large and high-risk patient population, 4) the 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 Multicenter Neonatal Research Network (NRN) Request for Applications and participate fully in all aspects of the NRN activities. This UAB clinical center has had the highest or second highest patient enrollment in 11 of 12 randomized controlled trials during the last two five year cycles of the NRN. In addition to the active participation in the NRN studies, the Division has been involved in the design and implementation of 14 multicenter and 7 single center randomized clinical trials during the last decade. The neonatologists in the Division decidedly support collaborative research and continued participation in the NRN. 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. On average, 1084 neonates are admitted per year to the Regional NICU at UAB. The well established referral patterns that include all NICUs in the state and the statewide perinatal health care system assure a large pool of high-risk admissions for clinical research in the coming years. 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, multidisdplinary High-Risk Newborn Follow-Up Program with over 90 percent compliance rate assures thorough long-term evaluation and care. Existing complementary maternal and infant data bases maintained by dedicated personnel are available for data retrieval, analysis, and research. Availability of three full-time experienced NRN nurses allows patient enrollment and protocol implementation 24 hours a day, 7 days a week. A protocol concept based on clinical studies and randomized trials in preterm infants that portend a large beneficial effect proposes a placebo-controlled randomized trial of diuretics that may reduce chronic lung disease. The proposed team of investigators at UAB will work with the NICHD and the NRN 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 NRN. 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 NRN.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HD034216-15
Application #
7803556
Study Section
Special Emphasis Panel (ZHD1-DSR-A (10))
Program Officer
Higgins, Rosemary
Project Start
1996-05-06
Project End
2011-03-31
Budget Start
2010-04-01
Budget End
2011-03-31
Support Year
15
Fiscal Year
2010
Total Cost
$225,794
Indirect Cost
Name
University of Alabama Birmingham
Department
Pediatrics
Type
Schools of Medicine
DUNS #
063690705
City
Birmingham
State
AL
Country
United States
Zip Code
35294
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