NICHD Cooperative Multicenter Neonatal Research Network

描述（由申请人提供）：概述。休斯敦大学是MFM和新生儿研究网络的成员。它向新生儿网络提供以下内容：庞大的、高风险的、不断增长的人口。2003年，我们的两家医院共有9212例分娩，1181例新生儿重症监护室住院，369例VLBW婴儿，这两家医院共有136张新生儿重症监护室床位：纪念赫尔曼医院（MHH），一家拥有大量转诊基础的私立医院，林登贝恩斯约翰逊综合医院（LBJ），一家主要为墨西哥裔美国人服务的县医院；2. 网络研究的总入学率高。在16个网络中心中，我们在低温和基准试验中排名第三，在光疗和谷氨酰胺试验中排名第二，在高级吸入一氧化氮试验中排名第一；3. 有临床研究经验并致力于网络的PI和CoPI。PI是Jon Tyson，医学博士，公共卫生硕士，临床研究和循证医学中心主任，围产期和儿科医疗保健研究Douglas K. Richardson奖获得者，以及临床研究培训项目主任协会颁发的杰出教育家奖。CoPI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主任和临床研究硕士学位课程。在过去的14年里，他们一直担任PI和CoPI（10年在达拉斯，4年在休斯顿），并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（最近发表了后续调查结果），指导并行研究委员会，并且是唯一一位自议定书审查委员会成立以来一直在其任职的PI。他还高度参与了体温降低试验（新英格兰杂志出版）；4. 多名优秀的教师在网络研究中担任主要角色。这些人包括a)布伦达·莫里斯，医学博士，她正在指导光疗法试验（现已完成登记；n = 1973例ELBW婴儿），她是支持试验的现场主任；b) Martin Blakely， MD， MS，一名儿科外科医生和K23接受者，他指导了最近完成的NEC观察性研究（第一篇论文发表，第二篇综述）。与泰森博士一起，他提议基于这些结果进行一项重大试验；c) Robert Lasky博士，美国国立卫生研究院资助的神经心理学家，他在光疗试验中指导听觉脑干诱发反应的重要子研究（来自休斯顿大学的50%的参与者）；d) Nehal Parikh， DO， K23奖获得者，他是正在进行的aEEG研究、支持试验的MRI二次研究和拟议的癫痫预防试验的现场主任；e) Sue Ramin，医学博士，MFM网络的PI和新生儿网络研究的倡导者；f) Larry Gilstrap，医学博士，产科主席，MFM网络首席执行官，新生儿网络咨询委员会成员；5. 方法论和多学科专业知识。泰森博士领导的中心为21名在生物伦理学、生物统计学、流行病学、卫生保健经济学和卫生服务研究方面具有专业知识的教师提供了现成的机会。

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.