Hypothermia for Pediatric Cardiac Arrest Planning Grant

描述(由申请人提供)：儿童时期的心肺骤停伴呼吸暂停和脉搏消失(CA)是一种悲剧性事件，经常导致死亡或质量较差的长期神经生存。最近在成人人群中进行的随机临床试验(RCT)报告了在院外室颤(VF)停止后接受短期亚低温治疗的患者的神经学结果和存活率的改善。低温对心脏骤停后儿童的疗效尚不清楚。儿童CA通常继发于导致缺氧的呼吸系统病因，而缺氧在一段时间后会导致心脏骤停。心跳停止或无脉搏电活动是复苏开始时最常见的心律失常。相比之下，在成年人中，突发心脏事件(没有之前的缺氧期)最常发生在室性颤动或室性心动过速，这是常见的表现节律。在这项临床试验计划拨款申请中，15家设有重症监护病房的儿科急救应用研究网络(PECARN)儿童医院将从门诊或住院环境中患有CA并恢复自主循环的患者的医疗记录中获得试点数据。这一人群的特征将包括特定的逮捕事件和病因、患者特征、住院过程、接受的干预措施、住院生存和神经学结果。这些信息将被用来建立纳入和排除标准，并计算未来儿童心脏骤停后低温随机对照试验的样本量要求。将估计从这15家儿童医院队列中成功招募患者参加未来RCT的持续时间。这一应用还将导致创建执行儿童心脏骤停后体温过低随机对照试验所需的多个文件，包括研究相关数据表、研究方案、操作手册、机构审查委员会和知情同意相关文件以及其他材料。PECARN将利用其现有的临床试验研究基础设施支持这一应用的所有阶段，该基础设施包括一个指导委员会、五个支持小组委员会的临床试验和一个中央数据管理协调中心(CDMCC)。CDMCC将运行该应用程序的所有数据和分析相关任务，并确保所有研究地点符合有关数据安全和保密的规定。

DESCRIPTION (provided by the applicant): Cardiopulmonary arrest with apnea and loss of palpable pulse (CA) in childhood is a tragic event that very often results in either death or poor quality long-term neurological survival. Recent randomized clinical trials (RCT) in adult populations have reported improved neurologic outcome and survival in groups that received short term mild hypothermia following out of hospital ventricular fibrillation (VF) arrest. The efficacy of hypothermia in children following cardiac arrest is not known. CA in children is commonly secondary to a respiratory etiology that results in hypoxia, which after a period of time results in cardiac arrest. Asystole or pulseless electrical activity are the most common presenting cardiac rhythms when resuscitation is initiated. In adults by contrast, a sudden cardiac event (without a preceding period of hypoxia) most often occurs with VF or ventricular tachycardia, the common presenting rhythms. In this clinical trial planning grant application, 15 Pediatric Emergency Care Applied Research Network (PECARN) children's hospitals with intensive care units will obtain pilot data from the medical records of patients who have sustained a CA with return of spontaneous circulation in either the outpatient or inpatient setting. Characterization of this population will include arrest specific events and etiology, patient characteristics, hospital course, interventions received, hospital survival, and neurologic outcome. This information will be used to create inclusion and exclusion criteria, and to calculate sample size requirements for a future RCT of hypothermia following pediatric cardiac arrest. Duration of time to successfully enroll patients from this cohort of 15 children's hospitals for a future RCT will be estimated. This application will also result in creation of multiple documents needed to perform a RCT of hypothermia after cardiac arrest in childhood including study related data forms, study protocols, manuals of operation, institutional review board and informed consent related documents, and other materials. The PECARN will support all phases of this application with its existing clinical trials research infrastructure that includes a steering committee, five clinical trials supporting subcommittees, and a central data management coordinating center (CDMCC). The CDMCC will make operational all data and analysis related tasks of this application, and assure all study sites are compliant with regulations concerning data security and confidentiality.