UT Houston has been a member of both the Neonatal and Maternal Fetal Medicine Research Networks since 2001. Large multicenter networks are needed to conduct large rigorous randomized trials that provide unbiased and generalizable answers to important clinical management questions. This renewal application for the Neonatal Research Network (NRN) proposes to 1) contribute to rigorously designed and executed clinical trials, 2) design and lead major trials of important management questions in the neonatal intensive care unit (NICU) 3) advance the methods in clinical research involving high-risk infants. The UT Houston site contributes: 1) a large NICU population (8653 births and 1837 NICU admissions in 2014) with racial and ethnic diversity (44% Black, 46% White, 31% Hispanic, 6% Asian in Generic Database) from two large NICUs, Children's Memorial Hermann Hospital (CMHH) and Memorial Southwest (MSW) within a single hospital system, 2) high enrollment in NRN studies (ranked 2nd and 5th of 18 centers in the two most recently completed large NRN trials, 3) skilled and committed PI and Alternate PI {Drs. Kennedy and Tyson have served as PI and Alternate PI for the past 24 years at UT Southwestern in Dallas and then at UT Houston. Together, they direct the Center for Clinical Research and Evidence-Based Medicine at UT Houston. They are known in the NRN for their commitment to rigorous research methods and for helping other investigators with study design. They have played major roles in the design, performance, and analysis of numerous completed and ongoing NRN randomized trials [e.g. Vitamin A, 4 Hypothermia trials, Phototherapy, Laparotomy vs Drainage for Necrotizing Enterocolitis (NEC)] and rigorous cohort studies of issues not addressable in trials [e.g. the widely used NRN estimator to assess prognosis of 22-25 wk. infants and the validation of screening criteria for retinopathy of prematurity (ROP) in 24-27 wk. infants]}, 4) talented multidisciplinary collaborators [Kevin Lally (Chair of Pediatric Surgery and leader in Laparotomy vs Drainage for NEC trial), Claudia Pedroza (a statistician involved in Bayesian analyses of multiple NRN studies), Charles Green (psychologist and statistician)]}, 5) strong support from clinical investigators as Chairman and Dean. Dr. Kennedy is the PI of a factorial trial of sodium supplementation and diuretics that has been approved by the NRN Steering Committee and could be implemented in the next cycle. Drs. Green and Tyson have an approved protocol to include a term reference group in the follow-up study (to determine appropriate cut-offs for Bayley III assessments) that could also be implemented if prioritized for NRN funding. To demonstrate our commitment and expertise, we include abstracts of several new proposals of pragmatic trials for consideration in the next funding cycle. In summary, the strengths of the this application include 1) a large diverse NICU population, 2) a strong track record in NRN study participation and local institutional support, and 3) multiple highly experienced investigators actively involved in the design, review, and interpretation of NRN studies.
In the US each year, approximately 300,000 infants are admitted to neonatal intensive care units. Over the past few decades, clinical research has greatly increased the survival of these infants, but many survivors have significant morbidity that persists into childhood and beyond. Multicenter studies with large, racially/ethnically diverse populations, like those of the Neonatal Research Network, are needed to conduct pragmatic clinical research to improve these outcomes; UT Houston has been an exemplary center in this network. .
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