Hypothermia for Pediatric Cardiac Arrest Planning Grant

描述（由申请人提供）：儿童期心肺骤停伴呼吸暂停和脉搏消失（CA）是一种悲剧性事件，通常会导致死亡或长期神经生存质量差。最近在成人人群中的随机临床试验（RCT）报告了在院外心室颤动（VF）骤停后接受短期轻度低温治疗的组的神经系统预后和生存率得到改善。儿童心脏骤停后低温治疗的疗效尚不清楚。儿童CA通常继发于呼吸系统病因，导致缺氧，一段时间后导致心脏骤停。当复苏开始时，最常见的心律是无脉搏或无心跳的电活动。相比之下，在成人中，突发的心脏事件（之前没有缺氧）通常伴随着室性心动过速或室性心动过速，这是常见的表现节律。在这项临床试验计划拨款申请中，15家儿科急诊应用研究网络（PECARN）设有重症监护病房的儿童医院将从门诊或住院的CA患者的医疗记录中获得试点数据。该人群的特征将包括骤停特定事件和病因、患者特征、住院过程、接受的干预措施、住院生存率和神经系统预后。这些信息将用于创建纳入和排除标准，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。从这15家儿童医院的队列中成功招募患者用于未来的随机对照试验所需的时间将被估计。该申请还将导致创建多个文件，以执行儿童心脏骤停后低温的随机对照试验，包括研究相关数据表格，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该申请的所有阶段，包括一个指导委员会、五个临床试验支持小组委员会和一个中央数据管理协调中心（CDMCC）。CDMCC将负责操作本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.