This proposal is a reapplication from the University of Texas Southwestern Medical Center (UTSW) to participate in the multi-center clinical program, the Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network (NRN). UTSW has been a member of the NRN since its inception in 1986. Dr. Myra Wyckoff, MD became Principal Investigator (PI) in September 2013 upon the departure of Pablo Snchez, MD and will remain as PI. Luc Brion, MD and Roy Heyne, MD continue to serve as Alternate PI and Follow-up PI, respectively. As an NRN clinical center, UTSW already has the necessary academic, research and clinical infrastructure in place to assure continued excellence in performance of NRN studies. The UTSW Neonatal- Perinatal Medicine (NPM) Division has demonstrated exceptional commitment to clinical research. In this endeavor, it has had the continuous strong support of the UTSW Pediatric Department as well as its clinical facilities, Parkland Memorial Hospital (PMH), and Children's Medical Center (CMC). PMH has one of the largest inborn delivery services in the United States. The CMC neonatal intensive care unit (NICU) is one of the largest referral units in the region and continues to expand. As a new component of the UTSW clinical program, the UTSW NPM Division has full support of the new UTSW Clment's University Hospital (CUH) where the clinical studies pertaining to this RFA will be performed in addition to PMH and CMC. The newly built CUH has a growing delivery service with a significant focus on high risk pregnancies and a state-of-the art facility. The Obstetric Department of UTSW and PHHS is part of the Maternal Fetal Medicine Unit, assuring a continued source of diverse patients for clinical studies. The patient population is predominantly Hispanic, an underserved but expanding population whose inclusion in clinical trials is essential in order to reduce the frequent health disparities in this ethnic group. UTSW has a proven track record within the NRN, as evidenced by its well organized clinical research system with a high percentage of eligible infants enrolled in randomized trials, excellence in conducting the studies, and complete data acquisition. Follow-up of study infants is integrated within the infant's medical home at CMC, and the follow-up rates are among the highest in the NRN. The PI has significant experience in the performance of translational and clinical trials and has successfully directed the multi-center, randomized clinical trials of the NRN since assuming the PI role. As a national leader in newborn resuscitation science, Dr. Wyckoff provides expertise to the NRN on issues of perinatal transition, stabilization and resuscitation following birth. Dr. Wyckoff and additional UTSW Faculty including Dr. Heyne (follow up PI), Dr. Brion (Alternate PI) and Dr. Chalak have each contributed to NRN concept proposals, studies, and publications.
The NRN is designed to perform interventional and observational clinical studies in newborns, particularly low birth weight infants. These studies are designed to improve the health of high risk newborns and infants.
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