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

NICHD 新生儿研究网络 (NRN)：临床中心（UG1 临床试验可选

• 批准号: 10682888
• 负责人: JON E. TYSON
• 金额: $ 34.32万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2030-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10682888
• 关键词: Address; Admission activity; Asian; Award; Bayesian Analysis; Bayesian Method; Beds; Biometry; Birth; Black race; Caring; Childhood; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Cohort Studies; Collaborations; Conduct Clinical Trials; Databases; Dedications; Development; Dose; Enrollment; Environment; Evidence Based Medicine; Faculty; Feasibility Studies; Future; Grant; Health; Health Sciences; Healthcare; Hispanic; Hour; Human Resources; Impairment; Infant; Infrastructure; Institution; Intervention; Leadership; Lipids; Low Birth Weight Infant; Maternal-Fetal Medicine Units Network; Maternal-fetal medicine; Medical; Mentors; Methodology; Methods; Mission; Morbidity - disease rate; Multicenter Neonatal Research Network; Multicenter Studies; National Institute of Child Health and Human Development; Necrotizing Enterocolitis; Neonatal; Neonatal Intensive Care Units; Neonatology; Neurodevelopmental Impairment; Newborn Infant; Not Hispanic or Latino; Obstetric Fetal Pharmacology; Operative Surgical Procedures; Outcome; Perinatal; Phototherapy; Population; Population Heterogeneity; Pregnancy; Premature Birth; Premature Infant; Probability; Productivity; Protocols documentation; Psychologist; Publishing; Race; Recording of previous events; Reference Standards; Reproducibility; Research; Research Design; Research Ethics; Research Infrastructure; Research Personnel; Role; Running; Science; Site; Statistical Models; Surgeon; Survivors; Talents; Texas; Time; United States National Institutes of Health; Universities; Vitamin D supplementation; career; clinical center; cohort; design; early-career faculty; economic evaluation; experience; extreme prematurity; follow-up; health economics; high risk infant; improved; innovation; intrapartum; medical schools; member; mortality; multidisciplinary; natural hypothermia; neonatal surgery; neonate; next generation; participant enrollment; perinatal medicine; programs; randomized, clinical trials; secondary outcome; skills; statistics; stillbirth; tool; web site

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.

项目总结