Hypothermia for Acute Brain Injury in Children

描述(由申请人提供)：德克萨斯大学休斯顿医学院的创伤性脑损伤(TBI)联盟主要致力于多中心临床研究。儿童创伤儿童基金会儿科外科和儿科副教授查尔斯·考克斯医学博士和儿童创伤儿童基金会儿科外科主任凯文·拉利医学博士是儿童创伤儿童基金会副教授。TBI联盟在识别和招募TBI患者进行跨多个医疗点的临床研究方面有着良好的记录。PI和Co-PI在儿科外科和外科危重护理方面都获得了委员会认证，这使得可以控制对脑损伤患者的急性护理管理。该组织还包括一个国家认可的住院和门诊康复中心(康复研究所，TIRR)。TIRR每年收治约750名患者，拥有36张床位的住院脑损伤病房。TIRR还拥有NIH/NIDRR资助的涉及脑损伤患者的临床研究的记录。康复后结果跟踪是自1982年以来进行结果研究的TBI部分的一个既定和成熟的组成部分。对儿童脑外伤的纵向研究目前在他们的5-9岁。休斯顿大学提供： (A)患者人数众多--德克萨斯大学休斯顿/赫尔曼纪念医院创伤服务中心每年收治约4,500名患者(958名患者，GCS评分为12分)，其中1,400名为儿科患者(167名12岁至21岁患者)。这一应用程序提供了管理严重颅脑损伤患者的专业知识和非常庞大的合格患者群体的罕见组合。 (B)方法学和多学科专业知识--PERS在基础和临床研究方面拥有丰富的经验。TBI团队成员在整个急性护理过程中拥有独特的临床专业知识，并在机构内部的TBI临床干预方案、康复和神经精神发育结果衡量标准的设计方面拥有丰富的经验。 (C)支持性领导和机构承诺--TBI联盟中的部门都表现出对支持协作临床研究的承诺。过去和正在进行的大量多中心试验以及由NICHD资助的两个临床研究(新生儿重症监护病房和产妇胎儿医学病房)网络在休斯顿大学的建立就证明了这一点。有一个由国立卫生研究院赞助的积极的临床研究课程和指导计划(K30 HL 04137)，旨在培训临床研究人员，以及一个拥有临床研究记录的大学临床研究中心(M01 RR02558)。

DESCRIPTION (provided by applicant): The Traumatic Brain Injury (TBI) Consortium at the University of Texas-Houston Medical School has a major commitment to multicenter clinical investigation. The PI, Charles Cox, M.D., is the Children's Fund for Pediatric Trauma Associate Professor of Surgery and Pediatrics and the Co-PI, Kevin Lally, M.D., the A.G. McNeese Professor and Chief of Pediatric Surgery. The TBI consortium has a track record for identifying and recruiting TBI patients for clinical studies across multiple points of care. The PI and Co-PI are board certified in both pediatric surgery and surgical critical care, which allows control of the acute care management of TBI patients. The group also includes a nationally recognized inpatient and outpatient rehabilitation center (The Institute for Rehabilitation and Research, TIRR). TIRR admits approximately 750 patients per year and has a 36-bed inpatient brain injury unit. TIRR also has a track record of NIH/NIDRR funded clinical research involving TBI patients. Post-rehabilitation outcomes follow-up is an established and mature component of the TBI component with outcome studies since 1982. Longitudinal studies of children with TBI are now in their 5th-9th year. UT-Houston provides: (A) A large patient population - Approximately 4,500 patients are admitted to the UT-Houston/Memorial Hermann Trauma Service per year (958 with a GCS of < 12), of which 1,400 are pediatric patients (167 with a GCS <12 between the ages 12-21). This application offers the rare combination of expertise in the management of patients with severe TBI and a very large, eligible patient population. (B) Methodological and multidisciplinary expertise - The Pls have extensive experience in basic and clinical research. The TBI team members have a unique combination of clinical expertise across the continuum of acute care, combined with extensive experience in TBI clinical intervention protocols, rehabilitation and the design of neuropsychiatric developmental outcome measures within the institution. (C) Supportive leadership and institutional commitment - The departments in the TBI consortium have all demonstrated a commitment to the support of collaborative clinical research. This is evidenced by the large number of past and ongoing multicenter trials and the establishment of the two NICHD-funded clinical research (Neonatal Intensive Care Units and Maternal Fetal Medicine Units) networks at UT-Houston. There is an active NIH sponsored Clinical Research Curriculum and Mentorship Program (K30 HL 04137) designed to train clinical investigators as well as a University Clinical Research Center (M01 RR02558) with a track record in clinical research.