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。PI，医学博士查尔斯考克斯，是儿童创伤基金会外科和儿科副教授和共同PI，凯文Lally，医学博士，司法部长McNeese教授和小儿外科主任。TBI联盟在识别和招募TBI患者进行跨多个护理点的临床研究方面有着良好的记录。PI和Co-PI在儿科手术和外科重症监护方面都获得了委员会认证，可以控制TBI患者的急性护理管理。该集团还包括一个国家认可的住院和门诊康复中心（康复和研究所，TIRR）。TIRR每年收治约750名患者，并拥有36张病床的住院脑损伤病房。TIRR还拥有NIH/NIDRR资助的涉及TBI患者的临床研究的跟踪记录。康复后结果随访是自1982年以来进行结果研究的TBI组成部分的既定和成熟组成部分。TBI儿童的纵向研究目前已进入第5 - 9年。UT-休斯顿提供： (A)大量患者人群-每年约有4，500名患者入住UT-休斯顿/纪念赫尔曼创伤服务中心（958名GCS < 12），其中1，400名为儿科患者（167名GCS <12，年龄在12-21岁之间）。 该应用程序提供了罕见的专业知识在严重TBI患者的管理和一个非常大的，合格的患者人群的组合。 (B)方法学和多学科专业知识-Pls在基础和临床研究方面具有丰富的经验。TBI团队成员在急性护理的连续性方面拥有独特的临床专业知识，并在TBI临床干预方案，康复和机构内神经精神发育结局措施的设计方面拥有丰富的经验。 (C)支持性领导和机构承诺-TBI联盟中的各个部门都表现出对合作临床研究的支持。过去和正在进行的大量多中心试验以及在德克萨斯大学休斯顿分校建立的两个NICHD资助的临床研究（新生儿重症监护室和产妇胎儿医学室）网络证明了这一点。有一个积极的NIH赞助的临床研究课程和导师计划（K30 HL 04137），旨在培训临床研究人员以及一个大学临床研究中心（M01 RR 02558），在临床研究中有良好的记录。

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.