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

基本信息

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
项目类别：
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

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

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项目摘要

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.

项目摘要休斯顿大学德克萨斯大学健康科学中心（UTH）一直是两者的生产成员 NICHD母体胎儿医学单元网络（MFMU网络）和新生儿研究网络（NRN），因为 2001年。在此应用程序中，我们建议支持NRN的使命：1）为NRN研究做出贡献这改善了新生儿的护理和成果，继续跻身NRN入学中心之列； 2）探索得克萨斯大学医学分公司（UTMB； in）的卫星网站的增加德克萨斯州加尔维斯顿（Galveston），距离休斯顿（Houston）约1小时车程），这是一个长期的MFMU网站，与UTH的合作者； 3）设计和领先对重要临床问题的严格研究； 4）推进设计方法，新生儿研究的进行，分析和传播； 5）指导下一代临床新生儿 - 境内医学研究人员。我们的优势包括：1）UTH的大量新生人口（2000 NICU入院； 33％西班牙裔，34％的黑人非西班牙裔，19％的白人非西班牙裔，6％的亚洲人，其他8％的其他/多个种族）随着UTMB的潜在增加而增加； 2）高度入学多个NRN研究（> 2100个注册自2016年以来进行NRN研究）； 3）强大而创新的后续计划（2年的随访> 90％；进行后续干预的RCT）； 4）高度投入和方法学熟练的PI（乔恩·泰森）和替代PI（Matthew Rysavy）具有> 65次临床试验，研究设计专业知识和分析以及多站点研究中的多个领导角色（自2016年以来NRN贡献：循环光疗法试验，坏死性小肠炎手术试验（NEST），术语参考研究，所有出生队列，NICHD 非常早产的出生结果工具）； 5）与团队科学的经验丰富的多学科合作者方法（例如，Claudia Pedroza，贝叶斯统计学家支持6个过去或正在进行的NRN试验的分析并促使NRN批准包括贝叶斯分析，以进行正在进行的和未来的NRN试验；马丁·布莱克利（Martin Blakely＆）凯文·拉利（Kevin Lally），带领NEST的儿科外科医生，这是NRN的首次新生儿手术试验；查尔斯·格林（Charles Green）心理学家，统计学家和PI用于术语参考研究；和其他具有孕产妇专业知识的人医学，生物统计学，健康经济学和研究伦理）； 6）才华横溢的早期职业调查员新生儿学，包括2个进行临床试验的NIH KL2学者研究； 7）强大的机构支持和临床研究基础设施。总而言之，此申请强调我们的大型研究入学率，经过验证的往绩记录，出色的后续计划，多学科和创新的环境，敬业的教职员工和领导力，并致力于增加通过进行严格的多中心研究，新生儿的护理和结果。