Multicenter Network of Neonatal Intensive Care Units

描述（由申请人提供）：德克萨斯大学休斯顿分校自2001年以来一直是新生儿和MFMU网络的成员。新生儿网络的更新申请旨在1)促进严格设计和执行的临床试验的开展；2)设计和实施至少一项针对NICU重要管理问题的主要试验和一项后续临床试验；3)推进涉及早产儿的临床研究方法。UT-Houston网络网站提供：1)庞大且不断增长的新生儿重症监护病房人口（2009年9937名新生儿和1775名ICU入院患者），种族和民族多样性[黑人30-38%，白人12-31%，西班牙裔25- 46%（两个实践站点范围）],2)网络研究的高入学率（在最近完成的两个大型网络试验的16个中心中排名第二和第六）熟练和承诺的PI和CoPI[博士]。肯尼迪和泰森在过去的19年里一直担任助教和副助教，其中7年在达拉斯大学，12年在德州大学休斯顿分校。他们共同指导临床研究和循证医学中心以及UT-Houston临床研究硕士学位课程。他们在网络中以严格的研究方法和帮助其他研究者进行研究设计而闻名。他们在许多已完成和正在进行的网络随机试验（维生素A、低温、光疗、NEC手术）的设计和实施中发挥了重要作用。4)大量有才华的合作者提供多学科专业知识[Kevin Lilly博士（儿科外科主席）和Tyson博士指导Martin Blakely博士（儿科外科医生，现在孟菲斯）开发正在进行的NEC试验手术]。Nehal Parikh博士是K23奖获得者，也是Kennedy博士和Tyson博士的指导者，他指导我们正在进行的6- 24小时低温试验。克劳迪娅·佩德罗萨博士是一名统计学家，由K12机构资助，对网络研究进行贝叶斯分析。本申请包括一项实用管理试验的概念应用，以比较NICU中两种常用但研究较少的管理策略的临床有效性、安全性和长期效果——积极利尿剂和严格限制液体使用与限制利尿剂预防支气管肺发育不良。

DESCRIPTION (provided by applicant): UT Houston has been a member of both the Neonatal and MFMU Networks since 2001. This renewal application for the Neonatal Network proposes to 1) contribute to the conduct of rigorously designed and executed clinical trials, 2) design and implement at least one major trial of an important management question in the NICU and one in the follow-up clinic, 3) advance the methods in clinical research involving preterm infants. The UT-Houston Network site provides: 1) A large and growing NICU population (9937 births and 1775 ICU admissions in 2009) with racial and ethnic diversity [30-38% Black, 12-31% White, 25- 46% Hispanic (ranges of two practice sites)], 2) High enrollment in Network studies (ranked 2nd and 6th of 16 centers in the two most recently completed large Network trials, 3) Skilled and committed PI and CoPI [Drs. Kennedy and Tyson have served as Pl and Co-PI for the past 19 years, 7 in Dallas and 12 at UT- Houston. Together, they direct the Center for Clinical Research and Evidence-Based Medicine and the Master's Degree Program in Clinical Research at UT-Houston. They are known in the Network for their commitment to rigorous research methods and for helping other investigators with study design. They have played major roles in the design and implementation of numerous completed and ongoing Network randomized trials (Vitamin A, Hypothermia, Phototherapy, Surgery for NEC).], 4) a large pool of talented collaborators to provide multidisciplinary expertise [Dr. Kevin Lilly (Chair of Pediatric Surgery) and Dr. Tyson mentored Dr. Martin Blakely (Pediatric Surgeon, now in Memphis) in developing the ongoing Surgery for NEC Trial. Dr. Nehal Parikh, a K23 awardee and mentee of Drs Kennedy and Tyson, directs the ongoing 6- 24 Hour Hypothermia Trial at our site. Dr. Claudia Pedroza is a statistician with institutional K12 funding to conduct Bayesian analyses of Network studies. This application includes a concept application of a pragmatic management trial to compare the clinical effectiveness, safety, and long-term effects of two commonly practiced but poorly studied management strategies in the NICU - aggressive diuretic and strict fluid restriction vs. restricted diuretic use for the prevention of bronchopulmonary dysplasia.