Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: multicentre randomised trial
Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: multicentre randomised trial
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DOI：
10.1016/s0140-6736(05)17946-x
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发表时间：
2005-02-19
期刊：
影响因子：
168.9
通讯作者：
Gunn, AJ
中科院分区：
文献类型：
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作者：
Gluckman, PD;Wyatt, JS;Gunn, AJ
研究背景脑低温可改善实验性围产期缺氧缺血的预后。我们做了一个多中心随机对照试验，以了解是否延迟头部冷却可以改善新生儿脑病的神经发育结局。方法234例中重度新生儿脑病和异常振幅整合脑电图（aEEG）的足月儿随机分为头部冷却72 h，出生6 h内，直肠温度维持在34- 35 ℃（n=116）或常规护理（n=118）。主要结局为18个月时死亡或严重残疾。分析是由意向treat. We研究在两个预定义的亚组分析的影响，低温在婴儿最严重的aEEG变化随机化之前，即，严重的背景振幅损失，和abnores-and那些不太严重的changes.Findings在16个婴儿，随访数据不可用。因此，在218名婴儿（93%）中，73/110名（66%）接受常规护理的婴儿和59/108名（55%）接受头部冷却的婴儿在18个月时死亡或严重残疾（比值比0.61; 95% CI 0.34-1-09，p=0.1）。使用逻辑回归模型调整aEEG变化的严重程度后，低温治疗的比值比为0.57（0.32-1.01，p=0.05）。临床重要并发症的发生率无差异。预先定义的亚组分析表明，头部冷却对aEEG变化最严重的婴儿没有影响（n=46，1.8; 0.49-6.4，p=0.51），但对aEEG变化不太严重的婴儿有益（n=172，0.42; 0.22-0.80，p=0.009）。解释这些数据表明，尽管诱导头部冷却在患有新生儿脑病的婴儿的混合群体中没有保护作用，它可以安全地提高生存率，而不会造成严重的神经发育不良。aEEG变化不太严重的婴儿残疾。
Background Cerebral hypothermia can improve outcome of experimental perinatal hypoxia-ischaemia. We did a multicentre randomised controlled trial to find out if delayed head cooling can improve neurodevelopmental outcome in babies with neonatal encephalopathy.Methods 234 term infants with moderate to severe neonatal encephalopathy and abnormal amplitude integrated electroencephalography (aEEG) were randomly assigned to either head cooling for 72 h, within 6 h of birth, with rectal temperature maintained at 34-35degreesC (n=116), or conventional care (n=118). Primary outcome was death or severe disability at 18 months. Analysis was by intention to treat. We examined in two predefined subgroup analyses the effect of hypothermia in babies with the most severe aEEG changes before randomisation-ie, severe loss of background amplitude, and seizures-and those with less severe changes.Findings In 16 babies, follow-up data were not available. Thus in 218 infants (93%), 73/110 (66%) allocated conventional care and 59/108 (55%) assigned head cooling died or had severe disability at 18 months (odds ratio 0.61; 95% CI 0.34-1-09, p=0.1). After adjustment for the severity of aEEG changes with a logistic regression model, the odds ratio for hypothermia treatment was 0.57 (0.32-1.01, p=0.05). No difference was noted in the frequency of clinically important complications. Predefined subgroup analysis suggested that head cooling had no effect in infants with the most severe aEEG changes (n=46, 1.8; 0.49-6.4, p=0.51), but was beneficial in infants with less severe aEEG changes (n=172, 0.42; 0.22-0.80, p=0.009).Interpretation These data suggest that although induced head cooling is not protective in a mixed population of infants with neonatal encephalopathy, it could safely improve survival without severe neurodevelopmental. disability in infants with less severe aEEG changes.