Planning Hypothermia Trial for Pediatric Cardiac Arrest
规划小儿心脏骤停的低温试验
基本信息
- 批准号:7146545
- 负责人:
- 金额:$ 18.89万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2006
- 资助国家:美国
- 起止时间:2006-08-01 至 2008-07-31
- 项目状态:已结题
- 来源:
- 关键词:automated medical record systemcardiovascular disorder therapychildrendisease /disorder prevention /controlearly /brief intervention /therapyexperimental designshandbookhealth related legalheart arresthuman therapy evaluationhypothermiamedical outreach /case findingmethod developmentnervous system disordernervous system disorder diagnosispediatricsrehabilitation
项目摘要
DESCRIPTION (provided by applicant): Cardiac arrest with apnea and loss of palpable pulse (CA) in childhood is a tragic event that often results in death or poor neurologic outcome. Recently, 2 adult randomized clinical trials (RCT) reported the use of mild hypothermia to improve both neurological outcome and survival in comatose survivors after ventricular fibrillation (VF). Similarly, recent RCTs in newborns with hypoxic-ischemic encephalopathy (HIE) also reported improved neurologic outcome after therapeutic hypothermia. For pediatric patients, no RCTs have been conducted of therapeutic hypothermia after CA and there are reasons for caution before widespread use. For example, children commonly have respiratory etiologies leading to a hypoxic period then CA; adults in contrast usually have a primary cardiac arrhythmia leading to sudden CA. In addition, children rarely develop VF as the initial rhythm causing CA as occurs in adults. Newborns with HIE, on the other hand, represent a unique birth associated event. We have current support to obtain cohort pilot data for planning of a RCT to examine the efficacy of therapeutic hypothermia after pediatric CA. This study is presently being completed at 15 sites associated with the Pediatric Emergency Care Applied Research Network (PECARN). Preliminary sample size estimates indicate that it will be feasible to conduct a RCT in 3 years of enrollment. This R34 application seeks funding to develop multiple documents and other materials necessary to accompany a RO1 application for a multicenter RCT of hypothermia in children who have sustained a CA. We plan to finalize inclusion and exclusion criteria and the sample size requirement for a future RCT; then we will confirm the length of patient enrollment required to perform the study at the 15 PECARN sites and recruit additional centers if needed to complete the enrollment phase of the RCT in 3 years. Additionally, we will develop the necessary documents to accompany a RO1 RCT application including a detailed manual of procedures (MOP) for the entire project, clinical research forms including web based forms for data entry, intra-institutional agreements, IRB related forms, and other study documents and forms described in detail within this application. Completion of this project will prepare our network to conduct a RCT of hypothermia for pediatric CA, as well as other high priority therapeutic interventional studies, aimed at improving outcomes of children who have sustained cardiac arrest.
描述(由申请人提供):儿童期心脏骤停伴呼吸暂停和可触及脉搏(CA)丧失是一种悲惨事件,通常导致死亡或神经功能结局不良。最近,2项成人随机临床试验(RCT)报道了使用亚低温改善室颤(VF)后昏迷幸存者的神经功能结局和生存率。类似地,最近在新生儿缺氧缺血性脑病(HIE)的随机对照试验中也报告了治疗性低温后神经功能结局的改善。对于儿科患者,尚未进行CA后治疗性低温的RCT,因此在广泛使用前应谨慎。例如,儿童通常具有导致缺氧期然后CA的呼吸病因;相比之下,成人通常具有导致突发CA的原发性心律失常。此外,儿童很少发展VF作为导致CA的初始节律,如成人中发生的那样。另一方面,新生儿缺氧缺血性脑病代表了一种独特的出生相关事件。我们目前的支持,以获得队列试点数据的规划随机对照试验,以检查治疗性低温后,儿童CA的疗效。这项研究目前正在与儿科急诊应用研究网络(PECARN)相关的15个研究中心完成。初步样本量估计表明,在入组后3年内进行RCT是可行的。该R34申请寻求资金,以开发多个文件和其他必要的材料,以伴随RO 1申请,用于持续CA儿童体温过低的多中心RCT。我们计划最终确定未来RCT的入选和排除标准以及样本量要求;然后我们将确认在15个PECARN研究中心进行研究所需的患者入组时间,并在需要时招募更多中心,以在3年内完成RCT的入组阶段。此外,我们将编写RO 1 RCT申请所需的文件,包括整个项目的详细程序手册(MOP)、临床研究表格(包括用于数据输入的网络表格)、机构内协议、IRB相关表格以及本申请中详细描述的其他研究文件和表格。该项目的完成将为我们的网络做好准备,以进行儿科CA的低温RCT以及其他高优先级的治疗干预研究,旨在改善持续心脏骤停儿童的结局。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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FRANK W MOLER其他文献
FRANK W MOLER的其他文献
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{{ truncateString('FRANK W MOLER', 18)}}的其他基金
1/2 Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
1/2 儿童冷却时间对心脏骤停患者疗效的影响 (P-ICECAP)
- 批准号:
10282853 - 财政年份:2021
- 资助金额:
$ 18.89万 - 项目类别:
1/2 Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
1/2 儿童冷却时间对心脏骤停患者疗效的影响 (P-ICECAP)
- 批准号:
10506042 - 财政年份:2021
- 资助金额:
$ 18.89万 - 项目类别:
1/2 Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
1/2 儿童冷却时间对心脏骤停患者疗效的影响 (P-ICECAP)
- 批准号:
10706518 - 财政年份:2021
- 资助金额:
$ 18.89万 - 项目类别:
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 - 财政年份:2003
- 资助金额:
$ 18.89万 - 项目类别:
Hypothermia for Pediatric Cardiac Arrest Planning Grant
低体温儿童心脏骤停计划补助金
- 批准号:
6686595 - 财政年份:2003
- 资助金额:
$ 18.89万 - 项目类别: