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。首席研究员查尔斯·考克斯（Charles Cox）医学博士是儿童创伤基金会的外科和儿科副教授，联合首席研究员凯文·拉利（Kevin Lally）医学博士是A.G.麦克尼斯教授和儿科外科主任。创伤性脑损伤联盟在识别和招募创伤性脑损伤患者进行临床研究方面有着良好的记录。PI和Co-PI在儿科外科和外科重症监护方面都获得了委员会认证，这可以控制TBI患者的急性护理管理。该集团还包括一个全国公认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，康复后结果随访是创伤性脑损伤组成部分中建立和成熟的组成部分。对创伤性脑损伤儿童的纵向研究现在已经是第5 -9年了。UT-Houston提供:

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.