Department of Pediatric Rehabilitation Medicine, Kennedy Krieger Institute, Baltimore, MD.
Department of Physical Medicine and Rehabilitation, Johns Hopkins University, Baltimore, MD.
Pediatr Crit Care Med. 2019 Jun;20(6):510-517. doi: 10.1097/PCC.0000000000001897.
To describe survival and 3-month and 12-month neurobehavioral outcomes in children with preexisting neurobehavioral impairment enrolled in one of two parallel randomized clinical trials of targeted temperature management.
Secondary analysis of Therapeutic Hypothermia after Pediatric Cardiac Arrest In-Hospital and Out-of-Hospital trials data.
Forty-one PICUs in the United States, Canada, and United Kingdom.
Eighty-four participants (59 in-hospital cardiac arrest and 25 out-of-hospital cardiac arrest), 49 males, 35 females, mean age 4.6 years (SD, 5.36 yr), with precardiac arrest neurobehavioral impairment (Vineland Adaptive Behavior Scales, Second Edition composite score < 70). All required chest compressions for greater than or equal to 2 minutes, were comatose and required mechanical ventilation after return of circulation.
Neurobehavioral function was assessed using the Vineland Adaptive Behavior Scales, Second Edition at baseline (reflecting precardiac arrest status), and at 3 and 12 months postcardiac arrest, followed by on-site cognitive evaluation. Vineland Adaptive Behavior Scales, Second Edition norms are 100 (mean) ± 15 (SD); higher scores indicate better function. Analyses evaluated survival, changes in Vineland Adaptive Behavior Scales, Second Edition, and cognitive functioning.
Twenty-eight of 84 (33%) survived to 12 months (in-hospital cardiac arrest, 19/59 (32%); out-of-hospital cardiac arrest, 9/25 [36%]). In-hospital cardiac arrest (but not out-of-hospital cardiac arrest) survival rate was significantly lower compared with the Therapeutic Hypothermia after Pediatric Cardiac Arrest group without precardiac arrest neurobehavioral impairment. Twenty-five survived with decrease in Vineland Adaptive Behavior Scales, Second Edition less than or equal to 15 (in-hospital cardiac arrest, 18/59 (31%); out-of-hospital cardiac arrest, 7/25 [28%]). At 3-months postcardiac arrest, mean Vineland Adaptive Behavior Scales, Second Edition scores declined significantly (-5; SD, 14; p < 0.05). At 12 months, Vineland Adaptive Behavior Scales, Second Edition declined after out-of-hospital cardiac arrest (-10; SD, 12; p < 0.05), but not in-hospital cardiac arrest (0; SD, 15); 43% (12/28) had unchanged or improved scores.
This study demonstrates the feasibility, utility, and challenge of including this population in clinical neuroprotection trials. In children with preexisting neurobehavioral impairment, one-third survived to 12 months and their neurobehavioral outcomes varied broadly.
描述在两项靶向体温管理平行随机临床试验中入组的存在预先存在的神经行为障碍的患儿的存活情况以及 3 个月和 12 个月的神经行为结局。
治疗性低温后儿科心脏骤停院内和院外试验数据的二次分析。
美国、加拿大和英国的 41 个 PICU。
84 名参与者(59 例院内心脏骤停和 25 例院外心脏骤停),49 名男性,35 名女性,平均年龄 4.6 岁(标准差,5.36 岁),存在心脏骤停前神经行为障碍(Vineland 适应行为量表,第二版综合评分<70)。所有患儿均需要按压大于或等于 2 分钟,处于昏迷状态,并在循环恢复后需要机械通气。
使用 Vineland 适应行为量表,第二版在基线时(反映心脏骤停前的状态)进行神经行为功能评估,并在心脏骤停后 3 个月和 12 个月进行现场认知评估。Vineland 适应行为量表,第二版的标准为 100(平均值)±15(标准差);得分越高表示功能越好。分析评估了存活率、Vineland 适应行为量表,第二版的变化以及认知功能。
84 名患儿中有 28 名(33%)存活至 12 个月(院内心脏骤停,19/59(32%);院外心脏骤停,9/25 [36%])。与无心脏骤停前神经行为障碍的治疗性低温后儿科心脏骤停组相比,院内心脏骤停的存活率显著降低(但院外心脏骤停组无显著差异)。25 名患儿的 Vineland 适应行为量表,第二版评分下降幅度小于或等于 15(院内心脏骤停,18/59(31%);院外心脏骤停,7/25 [28%])。心脏骤停后 3 个月,平均 Vineland 适应行为量表,第二版评分显著下降(-5;标准差,14;p<0.05)。12 个月时,院外心脏骤停后 Vineland 适应行为量表,第二版评分下降(-10;标准差,12;p<0.05),但院内心脏骤停后评分无变化(0;标准差,15);43%(12/28)的患儿评分不变或提高。
本研究证明了将该人群纳入临床神经保护试验的可行性、实用性和挑战性。在存在预先存在的神经行为障碍的患儿中,有三分之一存活至 12 个月,他们的神经行为结局差异很大。