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.

Public Health Relevance

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.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Clinical Research Cooperative Agreements - Single Project (UG1)
Project #
5UG1HD040689-17
Application #
9253246
Study Section
Special Emphasis Panel (ZHD1-DSR-A (50)R)
Program Officer
Raju, Tonse N
Project Start
2001-05-01
Project End
2021-03-31
Budget Start
2017-04-01
Budget End
2018-03-31
Support Year
17
Fiscal Year
2017
Total Cost
$275,338
Indirect Cost
$105,376
Name
University of Texas Sw Medical Center Dallas
Department
Pediatrics
Type
Schools of Medicine
DUNS #
800771545
City
Dallas
State
TX
Country
United States
Zip Code
75390
Bajaj, Monika; Natarajan, Girija; Shankaran, Seetha et al. (2018) Delivery Room Resuscitation and Short-Term Outcomes in Moderately Preterm Infants. J Pediatr 195:33-38.e2
Laptook, Abbot R; Bell, Edward F; Shankaran, Seetha et al. (2018) Admission Temperature and Associated Mortality and Morbidity among Moderately and Extremely Preterm Infants. J Pediatr 192:53-59.e2
Autmizguine, Julie; Tan, Sylvia; Cohen-Wolkowiez, Michael et al. (2018) Antifungal Susceptibility and Clinical Outcome in Neonatal Candidiasis. Pediatr Infect Dis J 37:923-929
Meyers, J M; Tan, S; Bell, E F et al. (2018) Neurodevelopmental outcomes among extremely premature infants with linear growth restriction. J Perinatol :
Boghossian, Nansi S; Do, Barbara T; Bell, Edward F et al. (2017) Efficacy of pharmacologic closure of patent ductus arteriosus in small-for-gestational-age extremely preterm infants. Early Hum Dev 113:10-17
Watterberg, K L; Fernandez, E; Walsh, M C et al. (2017) Barriers to enrollment in a randomized controlled trial of hydrocortisone for cardiovascular insufficiency in term and late preterm newborn infants. J Perinatol 37:1220-1223
Laptook, Abbot R; Shankaran, Seetha; Tyson, Jon E et al. (2017) Effect of Therapeutic Hypothermia Initiated After 6 Hours of Age on Death or Disability Among Newborns With Hypoxic-Ischemic Encephalopathy: A Randomized Clinical Trial. JAMA 318:1550-1560
Shankaran, Seetha; Laptook, Abbot R; Pappas, Athina et al. (2017) Effect of Depth and Duration of Cooling on Death or Disability at Age 18 Months Among Neonates With Hypoxic-Ischemic Encephalopathy: A Randomized Clinical Trial. JAMA 318:57-67
Chawla, Sanjay; Natarajan, Girija; Shankaran, Seetha et al. (2017) Markers of Successful Extubation in Extremely Preterm Infants, and Morbidity After Failed Extubation. J Pediatr 189:113-119.e2
Puopolo, Karen M; Mukhopadhyay, Sagori; Hansen, Nellie I et al. (2017) Identification of Extremely Premature Infants at Low Risk for Early-Onset Sepsis. Pediatrics 140:

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