Hypothermia for Pediatric Cardiac Arrest Planning Grant

低体温儿童心脏骤停计划补助金

• 批准号: 6781780
• 负责人: FRANK W MOLER
• 金额: $ 15.3万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-07-24 至 2006-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6781780
• 关键词: apnea; cardiovascular disorder epidemiology; clinical research; disease /disorder etiology; heart arrest; human data; human subject; human therapy evaluation; induced hypothermia; outcomes research; patient oriented research; pediatrics

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.

描述（由申请人提供）：儿童时期心肺骤停伴呼吸暂停和可触及脉搏（CA）消失是一种悲惨事件，常常导致死亡或长期神经存活质量差。最近在成年人群中进行的随机临床试验 (RCT) 报告称，在院外心室颤动 (VF) 骤停后接受短期轻度低温治疗的群体的神经系统结果和生存率有所改善。低温治疗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，一段时间后会导致心脏骤停。心搏停止或无脉电活动是复苏开始时最常见的心律。相比之下，在成人中，突发心脏事件（之前没有缺氧期）最常见于室颤或室性心动过速（常见的心律）。在本次临床试验计划资助申请中，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的患有CA并恢复自主循环的患者的病历中获取试点数据环境。该人群的特征包括逮捕具体事件和病因、患者特征、住院病程、接受的干预措施、医院生存率和神经系统结果。该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体温过低的随机对照试验的样本量要求。将估计从 15 家儿童医院成功招募患者参加未来随机对照试验所需的时间。该应用程序还将创建儿童心脏骤停后进行低温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该申请的所有阶段，其中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 将执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均符合有关数据安全和保密的法规。

项目成果

In-hospital versus out-of-hospital pediatric cardiac arrest: a multicenter cohort study.

院内与院外儿童心脏骤停：一项多中心队列研究。

• 发表时间: 2009-07
• 影响因子: 8.8
• 作者: Moler, Frank W;Meert, Kathleen;Donaldson, Amy E;Nadkarni, Vinay;Brilli, Richard J;Dalton, Heidi J;Clark, Robert S B;Shaffner, Donald H;Schleien, Charles L;Statler, Kimberly;Tieves, Kelly S;Hackbarth, Richard;Pretzlaff, Robert;van der Jagt, El
• 通讯作者: van der Jagt, El

Cardiac Arrest Outcomes in Children With Preexisting Neurobehavioral Impairment.

先前存在神经行为损伤的儿童的心脏骤停结果。

• 发表时间: 2019
• 作者: Christensen, James R;Slomine, Beth S;Silverstein, Faye S;Page, Kent;Holubkov, Richard;Dean, J Michael;Moler, Frank W;Therapeutic Hypothermia after Pediatric Cardiac Arrest (THAPCA) Trial Investigators
• 通讯作者: Therapeutic Hypothermia after Pediatric Cardiac Arrest (THAPCA) Trial Investigators

Multicenter cohort study of in-hospital pediatric cardiac arrest.

院内儿童心脏骤停的多中心队列研究。

• 发表时间: 2009-09
• 作者: Meert, Kathleen L;Donaldson, Amy;Nadkarni, Vinay;Tieves, Kelly S;Schleien, Charles L;Brilli, Richard J;Clark, Robert S B;Shaffner, Donald H;Levy, Fiona;Statler, Kimberly;Dalton, Heidi J;van der Jagt, Elise W;Hackbarth, Richard;Pretzlaff, Robe
• 通讯作者: Pretzlaff, Robe

Multicenter cohort study of out-of-hospital pediatric cardiac arrest.

院外儿童心脏骤停的多中心队列研究。

• 发表时间: 2011-01
• 影响因子: 8.8
• 作者: Moler, Frank W;Donaldson, Amy E;Meert, Kathleen;Brilli, Richard J;Nadkarni, Vinay;Shaffner, Donald H;Schleien, Charles L;Clark, Robert S B;Dalton, Heidi J;Statler, Kimberly;Tieves, Kelly S;Hackbarth, Richard;Pretzlaff, Robert;van der Jagt, El
• 通讯作者: van der Jagt, El

Early oxygenation and ventilation measurements after pediatric cardiac arrest: lack of association with outcome.

小儿心脏骤停后的早期氧合和通气测量：与结果缺乏关联。

• 发表时间: 2013-06
• 影响因子: 8.8
• 作者: Bennett, Kimberly Statler;Clark, Amy E;Meert, Kathleen L;Topjian, Alexis A;Schleien, Charles L;Shaffner, Donald H;Dean, J Michael;Moler, Frank W;Pediatric Emergency Care Medicine Applied Research Network
• 通讯作者: Pediatric Emergency Care Medicine Applied Research Network