From the Centre for the Developing Brain, King's College London (D.A., N.T., A.D.E.), Institute for Women's Health, University College London (N.M., P.B.), Institute of Clinical Sciences, Imperial College London (D.A., A.D.), and Homerton University Hospital (O.K.), London, the National Perinatal Epidemiology Unit Clinical Trials Unit, University of Oxford, Oxford (B.S., O.E., J.G., E.J., L.L., O.O.), Royal Maternity Hospital, Belfast (H.L.H.), University of Leeds, Leeds (M.L.), and University of Bristol, Bristol (M.T., A.W.) - all in the United Kingdom.
N Engl J Med. 2014 Jul 10;371(2):140-9. doi: 10.1056/NEJMoa1315788.
In the Total Body Hypothermia for Neonatal Encephalopathy Trial (TOBY), newborns with asphyxial encephalopathy who received hypothermic therapy had improved neurologic outcomes at 18 months of age, but it is uncertain whether such therapy results in longer-term neurocognitive benefits.
We randomly assigned 325 newborns with asphyxial encephalopathy who were born at a gestational age of 36 weeks or more to receive standard care alone (control) or standard care with hypothermia to a rectal temperature of 33 to 34°C for 72 hours within 6 hours after birth. We evaluated the neurocognitive function of these children at 6 to 7 years of age. The primary outcome of this analysis was the frequency of survival with an IQ score of 85 or higher.
A total of 75 of 145 children (52%) in the hypothermia group versus 52 of 132 (39%) in the control group survived with an IQ score of 85 or more (relative risk, 1.31; P=0.04). The proportions of children who died were similar in the hypothermia group and the control group (29% and 30%, respectively). More children in the hypothermia group than in the control group survived without neurologic abnormalities (65 of 145 [45%] vs. 37 of 132 [28%]; relative risk, 1.60; 95% confidence interval, 1.15 to 2.22). Among survivors, children in the hypothermia group, as compared with those in the control group, had significant reductions in the risk of cerebral palsy (21% vs. 36%, P=0.03) and the risk of moderate or severe disability (22% vs. 37%, P=0.03); they also had significantly better motor-function scores. There was no significant between-group difference in parental assessments of children's health status and in results on 10 of 11 psychometric tests.
Moderate hypothermia after perinatal asphyxia resulted in improved neurocognitive outcomes in middle childhood. (Funded by the United Kingdom Medical Research Council and others; TOBY ClinicalTrials.gov number, NCT01092637.).
在全身低温治疗新生儿缺氧缺血性脑病试验（TOBY）中，接受低温治疗的窒息性脑病新生儿在 18 个月时神经发育结局得到改善，但尚不确定这种治疗是否会带来更长期的神经认知益处。
我们将 325 名胎龄 36 周或以上的窒息性脑病新生儿随机分配，接受单纯标准治疗（对照组）或在出生后 6 小时内接受标准治疗联合体温降至 33 至 34°C 持续 72 小时的亚低温治疗。我们在 6 至 7 岁时评估这些儿童的神经认知功能。本分析的主要结局是智商评分 85 分或以上的生存率。
在低温组中，共有 145 名儿童中的 75 名（52%）生存且智商评分 85 分或以上，而在对照组中，共有 132 名儿童中的 52 名（39%）生存且智商评分 85 分或以上（相对风险，1.31；P=0.04）。低温组和对照组的死亡率相似（分别为 29%和 30%）。低温组中无神经异常的存活儿童比例高于对照组（65 名儿童中占 145 名[45%] vs. 37 名儿童中占 132 名[28%]；相对风险，1.60；95%置信区间，1.15 至 2.22）。在幸存者中，与对照组相比，低温组儿童患脑瘫的风险显著降低（21% vs. 36%，P=0.03），且患中重度残疾的风险显著降低（22% vs. 37%，P=0.03）；他们的运动功能评分也显著提高。两组间在父母对儿童健康状况的评估以及 11 项心理测试中的 10 项结果方面无显著差异。
围产期窒息后实施中度低温治疗可改善儿童中期的神经认知结局。（由英国医学研究理事会等资助；TOBY ClinicalTrials.gov 编号，NCT01092637。）
