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Childhood outcomes after hypothermia for neonatal encephalopathy

机译:新生儿脑病低温治疗后的儿童期结局

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BACKGROUND: We previously reported early results of a randomized trial of whole-body hypothermia for neonatal hypoxic-ischemic encephalopathy showing a significant reduction in the rate of death or moderate or severe disability at 18 to 22 months of age. Long-term outcomes are now available. METHODS: In the original trial, we assigned infants with moderate or severe encephalopathy to usual care (the control group) or whole-body cooling to an esophageal temperature of 33.5°C for 72 hours, followed by slow rewarming (the hypothermia group). We evaluated cognitive, attention and executive, and visuospatial function; neurologic outcomes; and physical and psychosocial health among participants at 6 to 7 years of age. The primary outcome of the present analyses was death or an IQ score below 70. RESULTS: Of the 208 trial participants, primary outcome data were available for 190. Of the 97 children in the hypothermia group and the 93 children in the control group, death or an IQ score below 70 occurred in 46 (47%) and 58 (62%), respectively (P = 0.06); death occurred in 27 (28%) and 41 (44%) (P = 0.04); and death or severe disability occurred in 38 (41%) and 53 (60%) (P = 0.03). Other outcome data were available for the 122 surviving children, 70 in the hypothermia group and 52 in the control group. Moderate or severe disability occurred in 24 of 69 children (35%) and 19 of 50 children (38%), respectively (P = 0.87). Attention-executive dysfunction occurred in 4% and 13%, respectively, of children receiving hypothermia and those receiving usual care (P = 0.19), and visuospatial dysfunction occurred in 4% and 3% (P = 0.80). CONCLUSIONS: The rate of the combined end point of death or an IQ score of less than 70 at 6 to 7 years of age was lower among children undergoing whole-body hypothermia than among those undergoing usual care, but the differences were not significant. However, hypothermia resulted in lower death rates and did not increase rates of severe disability among survivors. (Funded by the National Institutes of Health and the Eunice Kennedy Shriver NICHD Neonatal Research Network; ClinicalTrials.gov number, NCT00005772.)
机译:背景:我们先前报道了一项针对新生儿缺氧缺血性脑病的全身低温治疗的随机试验的早期结果,该试验显示了18至22个月大的死亡率或中度或严重残疾的发生率显着降低。现在可以获得长期结果。方法:在原始试验中,我们将中度或重度脑病的婴儿接受常规护理(对照组)或将全身冷却至33.5°C的食管温度持续72小时,然后缓慢复温(体温过低组)。我们评估了认知,注意力和执行力以及视觉空间功能。神经学结果;以及6至7岁的参与者的身体和心理社会健康状况。目前分析的主要结果是死亡或智商得分低于70。结果:在208名试验参与者中,有190名获得了主要结果数据。在低温治疗组的97名儿童和对照组的93名儿童中,死亡智商得分低于70的分别为46(47%)和58(62%)(P = 0.06);死亡发生在27(28%)和41(44%)(P = 0.04);死亡或严重残疾的发生率分别为38(41%)和53(60%)(P = 0.03)。尚有122名存活儿童的其他结果数据,低温治疗组70名,对照组52名。中度残疾或严重残疾分别发生在69名儿童中的24名(35%)和50名儿童中的19名(38%)中(P = 0.87)。低体温儿童和接受常规护理的儿童中,注意力执行功能障碍的发生率分别为4%和13%(P = 0.19),视觉空间功能障碍的发生率分别为4%和3%(P = 0.80)。结论:接受全身低温治疗的儿童的总死亡终点或智商得分低于70的6至7岁儿童的比率低于接受常规护理的儿童,但差异不显着。但是,体温过低导致死亡率降低,并且并未增加幸存者中的严重残疾率。 (由美国国立卫生研究院和Eunice Kennedy Shriver NICHD新生儿研究网络资助; ClinicalTrials.gov编号,NCT00005772。)

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