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.

Public Health Relevance

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.

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 #
5U10HD021373-29
Application #
8449188
Study Section
Special Emphasis Panel (ZHD1-DSR-A (03))
Program Officer
Raju, Tonse N
Project Start
1998-07-17
Project End
2016-03-31
Budget Start
2013-04-01
Budget End
2014-03-31
Support Year
29
Fiscal Year
2013
Total Cost
$280,427
Indirect Cost
$93,476
Name
University of Texas Health Science Center Houston
Department
Pediatrics
Type
Schools of Medicine
DUNS #
800771594
City
Houston
State
TX
Country
United States
Zip Code
77225
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
Srinivasan, Lakshmi; Page, Grier; Kirpalani, Haresh et al. (2017) Genome-wide association study of sepsis in extremely premature infants. Arch Dis Child Fetal Neonatal Ed 102:F439-F445
James, Jennifer; Munson, David; DeMauro, Sara B et al. (2017) Outcomes of Preterm Infants following Discussions about Withdrawal or Withholding of Life Support. J Pediatr 190:118-123.e4
Kennedy, Kathleen A; Mintz-Hittner, Helen A; BEAT-ROP Cooperative Group (2017) Medical and developmental outcomes of bevacizumab versus laser for retinopathy of prematurity. J AAPOS :
Denson, Lee A; McDonald, Scott A; Das, Abhik et al. (2017) Early Elevation in Interleukin-6 is Associated with Reduced Growth in Extremely Low Birth Weight Infants. Am J Perinatol 34:240-247
Shankaran, Seetha; Laptook, Abbot R; McDonald, Scott A et al. (2017) Acute Perinatal Sentinel Events, Neonatal Brain Injury Pattern, and Outcome of Infants Undergoing a Trial of Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy. J Pediatr 180:275-278.e2
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
Di Fiore, Juliann M; Martin, Richard J; Li, Hong et al. (2017) Patterns of Oxygenation, Mortality, and Growth Status in the Surfactant Positive Pressure and Oxygen Trial Cohort. J Pediatr 186:49-56.e1
Peralta-Carcelen, Myriam; Carlo, Waldemar A; Pappas, Athina et al. (2017) Behavioral Problems and Socioemotional Competence at 18 to 22 Months of Extremely Premature Children. Pediatrics 139:
Younge, Noelle; Goldstein, Ricki F; Bann, Carla M et al. (2017) Survival and Neurodevelopmental Outcomes among Periviable Infants. N Engl J Med 376:617-628

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