Childhood outcomes after hypothermia for neonatal encephalopathy.
Childhood outcomes after hypothermia for neonatal encephalopathy.
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DOI：
10.1056/nejmoa1112066
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发表时间：
2012-05-31
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影响因子：
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通讯作者：
Eunice Kennedy Shriver NICHD Neonatal Research Network
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作者：
Shankaran S;Pappas A;McDonald SA;Vohr BR;Hintz SR;Yolton K;Gustafson KE;Leach TM;Green C;Bara R;Petrie Huitema CM;Ehrenkranz RA;Tyson JE;Das A;Hammond J;Peralta-Carcelen M;Evans PW;Heyne RJ;Wilson-Costello DE;Vaucher YE;Bauer CR;Dusick AM;Adams-Chapman I;Goldstein RF;Guillet R;Papile LA;Higgins RD;Eunice Kennedy Shriver NICHD Neonatal Research Network
我们先前报道了一项全身低温治疗新生儿缺氧缺血性脑病的随机试验的早期结果，该试验显示18至22个月龄时死亡率或中度或重度残疾率显著降低。目前已取得长期成果。在最初的试验中，我们将患有中度或重度脑病的婴儿分配到常规护理（对照组）或全身冷却至食管温度33.5°C 72小时，然后缓慢复温（低温组）。我们评估了6至7岁的参与者的认知，注意力和执行，视觉空间功能;神经学结果;以及身体和心理社会健康。目前分析的主要结果是死亡或智商得分低于70。在208名试验参与者中，有190人的主要结局数据可用。在低温组的97名儿童和对照组的93名儿童中，分别有46名（47%）和58名（62%）儿童死亡或智商得分低于70（P = 0.06）;死亡分别为27例（28%）和41例（44%）（P = 0.04）;死亡或重度残疾分别为38例（41%）和53例（60%）（P = 0.03）。其他结果数据可用于122名存活儿童，低温组70名，对照组52名。中度或重度残疾分别发生在69名儿童中的24名（35%）和50名儿童中的19名（38%）（P = 0.87）。注意执行功能障碍分别发生在4%和13%的儿童接受低温和那些接受常规护理（P = 0.19），和视觉空间功能障碍发生在4%和3%（P = 0.80）。接受全身低温治疗的儿童在6 ~ 7岁时死亡或智商评分低于70的综合终点发生率低于接受常规治疗的儿童，但差异不显著。然而，低温导致死亡率降低，并没有增加幸存者的严重残疾率。（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，NCT 00005772。
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. 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. 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). 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.)