1/2 Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)

项目摘要 儿童院外心脏骤停是一种悲惨的事件，通常会导致死亡或永久死亡。 幸存者的脑损伤。在美国，每年有超过7000名儿童患有HCA，情况有所改善 就像成人一样，儿童的uchA结果很大程度上受到我们保护大脑免受全球气候变化影响的能力的限制 抢救成功者的脑缺血损伤。目标温度管理(TTM) 是目前指南推荐的治疗儿童的首选治疗方案 低温(TTM 32-34°C)高于常温(TTM 36-37.5°C)，以防止可能放大的发烧 脑部受伤。儿童治疗性低温治疗的最佳持续时间和患者选择标准仍然存在 未知和冷却设备并不是FDA专门批准的这一适应症。临床前数据和 机械学研究强烈表明，低温持续的时间比成年人通常使用的时间更长 可能会将脑损伤降至最低。这项研究将确定确定治疗的最佳持续时间(剂量) 低温可以改善预后，如果持续时间反应曲线的发展可以证实对 更广泛的儿科人群中的人权观察幸存者。我们假设较长的冷却时间将会改善。 与较短的降温时间相比，存活的患者存活并导致更好的神经恢复，因为 采用Vineland适应行为量表第三版(Vineland-3)评分进行评定。这样做的主要目标是 该项目是确定临床策略，以增加神经功能改善的患者数量 从HC A中恢复过来。这项试验的结果将对儿童产生极其显著的影响，并将立即 对临床实践和监管评估都有影响。降温时间对儿科疗效的影响 在心脏骤停患者(P-ICECAP)试验中，仿照正在进行的成人ICECAP试验，使用创新 自适应剂量发现方法，允许探索广泛的潜在持续时间并有效地 将主题分配到最能提供信息的地方。这项研究将利用 NHLBI/NINDS创新经验丰富的急诊临床试验网络(SIREN)战略 在儿科和成人试验中，目前正在进行ICECAP成人试验。警报器杠杆 现有资源，以实现规模经济并进行跨领域的重要临床研究 从入院前，通过急诊科和ICU住院，到出院后。

Project Summary Out-of-hospital cardiac arrest (OHCA) in children is a tragic event that usually results in death or permanent brain injury in survivors. More than 7000 children suffer OHCA each year in the US and improvements in pediatric OHCA outcomes, just as in adults, is very much limited by our ability to protect the brain from global cerebral ischemic injury in those who are successfully resuscitated. Targeted temperature management (TTM) is currently guideline-recommended in children following OHCA with preference stated for therapeutic hypothermia (TTM 32-34°C) over normothermia (TTM 36-37.5°C) in order to prevent fever which could amplify brain injury. The optimal duration and patient selection criteria for therapeutic hypothermia in children remain unknown and cooling devices are not specifically FDA approved for this indication. Preclinical data and mechanistic studies strongly suggest that durations of hypothermia longer than those typically used in adults may minimize brain injury. This study will determine if identifying an optimal duration (dose) of therapeutic hypothermia can improve outcomes, and if development of a duration response curve can confirm efficacy in a wider pediatric population of OHCA survivors. We hypothesize that longer durations of cooling will improve survival and result in better neurologic recovery in survivors compared to shorter cooling durations, as assessed by the Vineland Adaptive Behavior Scales–Third Edition (Vineland-3) score. The primary goal of this project is to identify clinical strategies that will increase the number of patients with improved neurological recovery from OHCA. The results of this trial will be extremely significant in children and will immediately impact both clinical practice and regulatory evaluation. The Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (P-ICECAP) trial, modeled after the ongoing adult ICECAP trial, uses innovative adaptive dose finding methods that allow exploration of a wide range of potential durations and efficiently allocate subjects where they will be most informative. The study will be conducted using resources of the NHLBI/NINDS Strategies to Innovate Emergency Care Clinical Trials Network (SIREN), which is experienced in both pediatric and adult trials, and is currently conducting the current adult ICECAP Trial. SIREN leverages existing resources to achieve economies of scale and to conduct important clinical investigations spanning from pre-hospital, through both the emergency department and ICU stay, and post hospital discharge.