Hypothermia for Acute Brain Injury in Children

低温治疗儿童急性脑损伤

• 批准号: 6631388
• 负责人: Charles S Cox
• 金额: $ 11.14万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-08-08 至 2005-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6631388
• 关键词: age difference; body temperature regulation; brain injury; functional ability; human subject; hypothermia; interdisciplinary collaboration; longitudinal human study; medical complication; nervous system disorder therapy; neuropsychological tests; neuropsychology; outcomes research; patient oriented research; pediatrics

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.

描述（由申请人提供）：德克萨斯大学休斯顿分校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。首席研究员 Charles Cox 医学博士是儿童儿科创伤基金会的外科和儿科副教授，联合首席研究员 Kevin Lally 医学博士是 A.G. McNeese 教授兼小儿外科主任。 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拥有良好的记录。 PI 和 Co-PI 在儿科外科和外科重症监护方面获得了委员会认证，可以控制 TBI 患者的急性护理管理。该集团还包括一个全国认可的住院和门诊康复中心（康复与研究学院，TIRR）。 TIRR 每年收治约 750 名患者，并拥有一个拥有 36 个床位的脑损伤住院病房。 TIRR 还拥有 NIH/NIDRR 资助的涉及 TBI 患者的临床研究的记录。自 1982 年以来，康复后结局随访是 TBI 组成部分的一个成熟且成熟的组成部分，其结局研究自 1982 年以来一直在进行。对 TBI 儿童的纵向研究目前已进入第 5-9 年。德州大学休斯顿分校提供： (A) 患者群体庞大——每年约有 4,500 名患者被 UT-休斯顿/纪念赫尔曼创伤服务中心收治（958 名 GCS < 12），其中 1,400 名儿童患者（167 名 12-21 岁之间 GCS <12）。 该应用程序罕见地结合了严重 TBI 患者管理方面的专业知识和庞大的合格患者群体。 (B) 方法论和多学科专业知识 - Pls 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，并在机构内的 TBI 临床干预方案、康复和神经精神发育结果测量设计方面拥有丰富的经验。 (C) 支持性领导和机构承诺——TBI 联盟的各个部门都表现出了对支持合作临床研究的承诺。过去和正在进行的大量多中心试验以及在 UT-休斯顿大学建立的两个 NICHD 资助的临床研究网络（新生儿重症监护病房和母胎医学病房）网络就证明了这一点。有一个活跃的 NIH 赞助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，以及一个在临床研究方面拥有良好记录的大学临床研究中心 (M01 RR02558)。