NICHD Neonatal Research Network (NRN): Clinical Centers (UG1 Clinical Trial Optional

PROJECT SUMMARY The University of Texas Health Science Center at Houston (UTH) has been a productive member of both the NICHD Maternal Fetal Medicine Unit Network (MFMU Network) and Neonatal Research Network (NRN) since 2001. In this application, we propose to support the mission of the NRN by: 1) contributing to NRN research

that improves care and outcomes for newborns, continuing to rank among the top NRN centers for enrollment; 2) exploring the addition of a collaborating satellite site, University of Texas Medical Branch (UTMB; in Galveston, TX, ~1 hour drive from Houston), a long-time MFMU Network site and collaborator with UTH; 3)

designing and leading rigorous studies of important clinical questions; 4) advancing the methods of design, conduct, analysis, and dissemination of neonatal research; 5) mentoring the next generation of clinical researchers in neonatal-perinatal medicine. Our strengths include: 1) a large and diverse neonatal population at UTH (2000 NICU admissions; 33%

Hispanic, 34% Black non-Hispanic, 19% White non-Hispanic, 6% Asian, 8% other/multiple races) that would be increased with the potential addition of UTMB; 2) high enrollment in multiple NRN studies (>2100 enrollments to NRN studies since 2016); 3) a strong and innovative follow-up program (>90% follow-up at 2-years;

conducting RCTs of follow-up interventions); 4) highly committed and methodologically skilled PI (Jon Tyson) and Alternate PI (Matthew Rysavy) with experience of >65 clinical trials, expertise in study design and analysis, and multiple leadership roles in multisite studies (NRN contributions since 2016: Cycled Phototherapy

Trial, Necrotizing Enterocolitis Surgery Trial (NEST), Term Reference Study, All Birth Cohort, NICHD Extremely Preterm Birth Outcome Tool); 5) experienced multidisciplinary collaborators with a team-science approach (e.g., Claudia Pedroza, a Bayesian statistician supporting analyses of 6 past or ongoing NRN trials

and prompting NRN approval to include Bayesian analyses for ongoing and future NRN trials; Martin Blakely & Kevin Lally, pediatric surgeons who led NEST, the first neonatal surgical trial in the NRN; Charles Green, a psychologist, statistician, and PI for Term Reference Study; and others with expertise in maternal-fetal

medicine, biostatistics, health economics, and research ethics); 6) talented early career investigators in neonatology, including 2 NIH KL2 scholars conducting clinical trials that may be proposed as future NRN studies; and 7) robust institutional support and clinical research infrastructure. In summary, this application

emphasizes our large and diverse study enrollment, proven track record, excellent follow-up program, multidisciplinary and innovative environment, dedicated faculty and leadership, and a commitment to augment the care and outcomes of neonates through the conduct of rigorous multicenter research.