IH11 in Randomized Controlled Trial of Induced Hypothermia for Hypoxic-Ischemic Encephalopathy in Term Infants

Dataset IH11
Study Description
This large multicenter trial tested whether cerebral cooling initiated within 6 hours of birth and continued for 72 hours would reduce the risk of death and moderate to severe neurodevelopmental injury at 18-22 months corrected age. Infants at least 36 weeks gestation with an abnormal blood gas within 1 hour of birth, or a history of an acute perinatal event and a 10-min Apgar score <5, or continued need for ventilation were screened. Following a neurological exam, those with moderate to severe encephalopathy were randomized to a 72-hour period of total body cooling (cooling blanket, followed by slow re-warming). Infants enrolled in the trial were gestational age of at least 36 weeks who were admitted to the hospital at or before six hours of age who had moderate or severe encephalopathy.

数据集IH11
研究概况
本项大型多中心试验旨在评估，于出生后6小时内启动并持续72小时的脑部低温治疗，能否降低校正年龄（corrected age）18~22月龄时的死亡风险与中重度神经发育损伤的发生率。
本研究对符合以下任一条件的胎龄（gestational age）满36周及以上的新生儿进行筛选：出生后1小时内血气分析结果异常；存在急性围产期事件病史且10分钟阿普加评分（Apgar score）<5分；仍需持续机械通气。
经神经系统检查确诊为中重度脑病的新生儿，将被随机分配接受72小时全身低温治疗（采用降温毯实施，后续予以缓慢复温）。
本试验纳入的受试者均为胎龄满36周及以上、于出生后6小时内入院且确诊中重度脑病的新生儿。