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.

项目概要 德克萨斯大学休斯敦健康科学中心 (UTH) 一直是这两个组织的富有成效的成员 NICHD 母胎医学单位网络 (MFMU Network) 和新生儿研究网络 (NRN) 自 2001。在此申请中，我们建议通过以下方式支持 NRN 的使命：1) 为 NRN 研究做出贡献 改善新生儿护理和治疗结果，继续跻身顶级 NRN 注册中心之列； 2) 探索增加一个合作卫星站点，德克萨斯大学医学分部 (UTMB；在 德克萨斯州加尔维斯顿，距休斯顿约 1 小时车程），是 MFMU 网络的长期站点，也是 UTH 的合作者； 3） 设计和领导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 新生儿围产期医学研究人员。 我们的优势包括：1) UTH 拥有大量且多样化的新生儿群体（2000 名 NICU 入院人数；33% 西班牙裔、34% 非西班牙裔黑人、19% 非西班牙裔白人、6% 亚洲人、8% 其他/多种种族） 随着 UTMB 的潜在增加而增加； 2) 多项 NRN 研究的高入学率（>2100 名入学者） 自 2016 年起参与 NRN 研究）； 3）强大且创新的随访计划（2年随访率>90%； 进行后续干预措施的随机对照试验）； 4) 高度忠诚且方法论熟练的 PI（乔恩·泰森） 候补 PI (Matthew Rysavy)，拥有超过 65 项临床试验经验，在研究设计和 分析以及多中心研究中的多重领导角色（自 2016 年以来 NRN 的贡献：循环光疗 试验，坏死性小肠结肠炎手术试验 (NEST)，术语参考研究，所有出生队列，NICHD 极早产结果工具）； 5) 经验丰富、具有团队科学精神的多学科合作者 方法（例如，Claudia Pedroza，一位贝叶斯统计学家，支持对 6 项过去或正在进行的 NRN 试验进行分析 并促使 NRN 批准将贝叶斯分析纳入正在进行和未来的 NRN 试验中；马丁·布莱克利 & Kevin Lally，小儿外科医生，领导 NEST，这是 NRN 的第一个新生儿手术试验；查尔斯·格林，一个 心理学家、统计学家和术语参考研究的 PI；以及其他具有母胎专业知识的人 医学、生物统计学、卫生经济学和研究伦理学）； 6）有才华的早期职业调查员 新生儿学，包括 2 名 NIH KL2 学者正在进行可能被提议作为未来 NRN 的临床试验 研究； 7) 强大的机构支持和临床研究基础设施。总结一下，这个应用 强调我们庞大且多样化的学习入学人数、良好的记录、出色的后续计划， 多学科和创新的环境、敬业的教师和领导力以及增强的承诺 通过进行严格的多中心研究来了解新生儿的护理和结果。