UT Houston has been a member of both the Neonatal and MFMU Networks since 2001. This renewal application for the Neonatal Network proposes to 1) contribute to the conduct of rigorously designed and executed clinical trials, 2) design and implement at least one major trial of an important management question in the NICU and one in the follow-up clinic, 3) advance the methods in clinical research involving preterm infants. The UT-Houston Network site provides: 1) A large and growing NICU population (9937 births and 1775 ICU admissions in 2009) with racial and ethnic diversity [30-38% Black, 12-31% White, 25- 46% Hispanic (ranges of two practice sites)], 2) High enrollment in Network studies (ranked 2nd and 6th of 16 centers in the two most recently completed large Network trials, 3) Skilled and committed PI and CoPI [Drs. Kennedy and Tyson have served as Pl and Co-PI for the past 19 years, 7 in Dallas and 12 at UT- Houston. Together, they direct the Center for Clinical Research and Evidence-Based Medicine and the Master's Degree Program in Clinical Research at UT-Houston. They are known in the Network for their commitment to rigorous research methods and for helping other investigators with study design. They have played major roles in the design and implementation of numerous completed and ongoing Network randomized trials (Vitamin A, Hypothermia, Phototherapy, Surgery for NEC).], 4) a large pool of talented collaborators to provide multidisciplinary expertise [Dr. Kevin Lilly (Chair of Pediatric Surgery) and Dr. Tyson mentored Dr. Martin Blakely (Pediatric Surgeon, now in Memphis) in developing the ongoing Surgery for NEC Trial. Dr. Nehal Parikh, a K23 awardee and mentee of Drs Kennedy and Tyson, directs the ongoing 6- 24 Hour Hypothermia Trial at our site. Dr. Claudia Pedroza is a statistician with institutional K12 funding to conduct Bayesian analyses of Network studies. This application includes a concept application of a pragmatic management trial to compare the clinical effectiveness, safety, and long-term effects of two commonly practiced but poorly studied management strategies in the NICU - aggressive diuretic and strict fluid restriction vs. restricted diuretic use for the prevention of bronchopulmonary dysplasia.
In the US each year, approximately 400,000 infants are admitted to neonatal intensive care units because of prematurity or birth defects. Over the past several decades, clinical research has greatly improved the survival prospects for these infants, but many survivors have significant morbidity that persists into childhood and beyond. Ongoing pragmatic clinical research is needed to improve these outcomes.
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