NICHD Cooperative Multicenter Neonatal Research Network

描述(申请人提供)：概述。德克萨斯大学休斯顿分校是MFM和新生儿研究网络的成员。它为新生儿网络提供了以下内容：1.庞大、高风险且不断增长的人口。2003年，我们的两家医院共有9212例分娩、1181例NICU入院和369例极低出生体重儿，这两家医院总共有136张NICU床位：纪念赫尔曼医院(MHH)和林登·贝恩斯·约翰逊综合医院(LBJ)，前者是一家拥有庞大转诊基础的私立医院，后者是一家以墨西哥裔美国人为主的县医院；2.参加网络研究的总人数很高。我们在16个网络中心中排名第三，在低温和基准试验中排名第二，在光疗和谷氨酰胺试验中排名第二，在Premie吸入性一氧化氮试验中排名第一；3.一个精通临床研究并致力于网络的PI&COPI。PIE是乔恩·泰森，医学博士，公共卫生硕士，临床研究和循证医学中心主任，获得道格拉斯·K·理查森围产期和儿科保健研究奖和临床研究培训项目主任协会颁发的杰出教育者奖。副本是凯瑟琳·肯尼迪，医学博士，公共卫生硕士，围产期流行病学项目和临床研究硕士项目主任。在过去的14年里，他们一直担任私家侦探和副手(在达拉斯有10年，在休斯顿有4年)，以致力于模范研究和帮助其他调查人员而闻名。泰森博士担任维生素A委员会主席(最近发表的后续研究结果)，同时领导同时研究委员会，是自议定书审查委员会成立以来唯一连续担任该委员会成员的非政府组织。他还高度参与了低温试验(见《新英格兰杂志》)；4.在网络研究中担任主要角色的多名有才华的教员。这些人包括a)领导光疗试验的布伦达·莫里斯医学博士(注册现已完成；n=1973名ELBW婴儿)和支持试验的现场主任；b)马丁·布莱克利，医学博士，医学硕士，儿科外科医生和K23接受者，他领导了最近完成的NEC观察性研究(第一篇手稿已发表；第二篇评论中)。与泰森博士一起，他正在提议一项基于结果的重大试验；c)罗伯特·拉斯基，博士，NIH资助的神经心理学家，正在领导光疗试验中听觉脑干诱发反应的一个重要子研究(&gt；50%来自休斯顿大学)；d)Nehal Parikh，Do，K23奖获得者，正在进行的AEEG研究、支持性试验的MRI二次研究和拟议的癫痫预防试验的现场主任；e)MFM网络的Sue Ramin，医学博士，PI，新生儿网络研究的倡导者；和f)拉里·吉尔斯特拉普，医学博士，产科主席，MFM网络公司PI，新生儿网络咨询委员会成员；5.方法学和多学科专业知识。泰森博士领导的中心提供了21名具有生物伦理学、生物统计学、流行病学、卫生保健经济学和卫生服务研究专业知识的教职员工。

DESCRIPTION (provided by applicant): OVERVIEW. UT Houston is a member of both the MFM and Neonatal Research Networks. It provides the following to the Neonatal Network: 1. A large, high-risk, and growing population. In 2003, we had a total of 9212 deliveries, 1181 NICU admissions, & 369 VLBW infants in our 2 hospitals which house 136 total NICU beds: Memorial Hermann Hospital (MHH), a private hospital with a large referral base, and Lyndon Baines Johnson General Hospital, (LBJ), a county hospital serving a largely Mexican American population; 2. High total enrollment in Network studies. We ranked 3rd of 16 Network centers in the Hypothermia & Benchmarking Trials, 2nd in the Phototherapy & Glutamine Trials, and 1st in the Premie Inhaled Nitric Oxide Trial; 3. A PI & CoPI skilled in clinical research & committed to the Network. The PI is Jon Tyson, MD, MPH, Director of the Center for Clinical Research and Evidence Based Medicine & recipient of the Douglas K. Richardson Award for perinatal and pediatric healthcare research and the Distinguished Educator Award from the Association of Clinical Research Training Program Directors. The CoPI is Kathleen Kennedy, MD, MPH, Director of the Perinatal Epidemiology Program and the Master's Degree Program in Clinical Research. They have served as PI and CoPI for the past 14 years (10 in Dallas & 4 in Houston) and are known for their dedication to exemplary research & helping other investigators. Dr. Tyson chaired the Vitamin A Committee (follow-up findings recently published), directs the Concurrent Research Committee, and is the only PI to have served continuously on the Protocol Review Committee since its inception. He has also been highly involved in the Hypothermia Trial (in press, New England Journal); 4. Multiple talented faculty taking major roles in Network research. These include a) Brenda Morris, MD who is directing the Phototherapy Trial (enrollment now completed; n = 1973 ELBW infants) and is site director for the SUPPORT Trial; b) Martin Blakely, MD, MS, a pediatric surgeon & K23 recipient who directed the recently completed the NEC Observational Study (1st manuscript published; 2nd in review). With Dr. Tyson, he is proposing a major trial based on the results; c) Robert Lasky, PhD, an NIH-funded neuropsychologist who is directing an important substudy of auditory brainstem evoked responses in the Phototherapy Trial (>50% of enrollment from UT Houston); d) Nehal Parikh, DO, a K23 award recipient, who is the site director for the ongoing aEEG study, the MRI secondary study of the Support Trial, and the proposed seizure prophylaxis trial; e) Sue Ramin, MD, PI of the MFM Network and advocate for Neonatal Network studies; and f) Larry Gilstrap, MD, Chairman of Obstetrics, Co PI of the MFM Network, and Neonatal Network Advisory Board member; 5. Methodological & multi-disciplinary expertise. The Center that Dr. Tyson directs provides ready access to 21 faculty with expertise in bioethics, biostatistics, epidemiology, health care economics, and health services research.