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

项目摘要 得克萨斯大学休斯顿健康科学中心（UTH）一直是两个富有成效的成员， NICHD产妇胎儿医学单位网络（MFMU网络）和新生儿研究网络（NRN 2001.在本申请中，我们建议通过以下方式支持NRN的使命：1）为NRN的研究做出贡献 改善新生儿的护理和结果，继续在NRN注册中心中名列前茅; 2)探索增加一个合作卫星站点，德克萨斯大学医学分支（UTMB;在 加尔维斯顿，德克萨斯州，距离休斯顿约1小时车程），长期MFMU网络站点，与UTH合作; 3） 设计和领导重要临床问题的严格研究; 4）推进设计方法， 新生儿研究的开展、分析和传播; 5）指导下一代临床 围产期医学的研究人员。 我们的优势包括：1）UTH的新生儿人口众多且多样化（2000名新生儿重症监护室入院; 33% 西班牙裔，34%黑人非西班牙裔，19%白色非西班牙裔，6%亚洲人，8%其他/多种族）， 随着UTMB的潜在增加而增加; 2）多项NRN研究的高入组率（>2100例入组 自2016年以来的NRN研究）; 3）强大且创新的随访计划（2年随访率>90%; 进行随访干预的随机对照试验）; 4）高度承诺和方法熟练的PI（Jon Tyson） 和替代PI（Matthew Rysavy），具有>65项临床试验的经验，研究设计方面的专业知识， 分析，以及多地点研究中的多个领导角色（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 极端早产结局工具）; 5）经验丰富的多学科合作者与团队科学 方法（例如，Claudia Pedroza，贝叶斯统计学家，支持对6项既往或正在进行的NRN试验的分析 并促使NRN批准将贝叶斯分析纳入正在进行的和未来的NRN试验;马丁布莱克利& Kevin Lally，领导NEST的儿科外科医生，这是NRN的第一个新生儿手术试验; Charles绿色，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， 神经病学，包括2名NIH KL 2学者进行临床试验，可能被提议作为未来的NRN 研究;以及7）强大的机构支持和临床研究基础设施。总之，本申请 强调我们的大规模和多样化的研究招募，良好的跟踪记录，出色的后续计划， 多学科和创新的环境，专门的教师和领导，并承诺增加 通过开展严格的多中心研究，提高新生儿的护理和结局。

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.