Whole-Body Hypothermia for Term and Near-Term Newborns With Hypoxic-Ischemic Encephalopathy A Randomized Controlled Trial
Whole-Body Hypothermia for Term and Near-Term Newborns With Hypoxic-Ischemic Encephalopathy A Randomized Controlled Trial
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DOI：
10.1001/archpediatrics.2011.43
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发表时间：
2011-08-01
影响因子：
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通讯作者：
Doyle, Lex W.
中科院分区：
文献类型：
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作者：
Jacobs, Susan E.;Morley, Colin J.;Doyle, Lex W.
目的：确定中度全身低温治疗新生儿缺氧缺血性脑病的有效性和安全性，这些新生儿出生在有和没有新生儿重症监护设施或复杂的低温设备的医院。设计：多中心，国际，随机对照试验。从2001年2月到2007年7月，澳大利亚、新西兰、加拿大和美国（N = 28）的新生儿重症监护病房。参与者：妊娠35周或以上的新生儿，具有围产期缺氧缺血和中度至重度临床脑病的指标，随机分配到低温组（n = 110）或标准护理组（n = 111）。干预：全身低温至33.5 ℃持续72小时或标准护理（37 ℃）。接受低温治疗的婴儿在周围环境温度下通过关闭辐射加热器进行治疗，然后应用冷藏凝胶包将直肠温度维持在33摄氏度至34摄氏度。主要结果测量：2岁时死亡或主要感觉神经残疾。结果：治疗性低温降低了2岁时死亡或主要感觉神经残疾的风险：在2年时，低温组107名婴儿中有55名（51.4%）和对照组101名婴儿中有67名（66.3%）死亡或有严重的感觉神经性残疾（风险比，0.77 [95%置信区间，0.62-0.98]; P = 0.03）。死亡率下降，无任何感觉神经残疾的存活率增加。低温的不良影响是minimal.Conclusions：全身低温是有效的，似乎是安全的，当开始在6小时内出生在医院出生的足月和近足月新生儿缺氧缺血性脑病。这种简单的低温方法可以在严格的协议中使用，并在等待检索和运送到区域新生儿重症监护室时，对正确诊断和在非三级新生儿环境中应用低温进行适当的培训。
Objective: To determine the effectiveness and safety of moderate whole-body hypothermia in newborns with hypoxic-ischemic encephalopathy born in hospitals with and without newborn intensive care facilities or complicated hypothermia equipment.Design: Multicenter, international, randomized controlled trial.Setting: Neonatal intensive care units in Australia, New Zealand, Canada, and the United States (N = 28) from February 2001 through July 2007.Participants: Newborns of 35 weeks' gestation or more, with indicators of peripartum hypoxia-ischemia and moderate to severe clinical encephalopathy, randomly allocated to hypothermia (n = 110) or standard care (n = 111).Intervention: Whole-body hypothermia to 33.5 degrees C for 72 hours or standard care (37 degrees C). Infants who received hypothermia were treated at ambient environmental temperature by turning off the radiant warmer and then applying refrigerated gel packs to maintain rectal temperature at 33 degrees C to 34 degrees C.Main Outcome Measures: Death or major sensorineural disability at 2 years of age.Results: Therapeutic hypothermia reduced the risk of death or major sensorineural disability at 2 years of age: 55 of 107 infants (51.4%) in the hypothermia group and 67 of 101 infants (66.3%) in the control group died or had a major sensorineural disability at 2 years (risk ratio, 0.77 [95% confidence interval, 0.62-0.98]; P = .03). The mortality rate decreased, and the survival rate free of any sensorineural disability increased. Adverse effects of hypothermia were minimal.Conclusions: Whole-body hypothermia is effective and appears to be safe when commenced within 6 hours of birth at the hospital of birth in term and near-term newborns with hypoxic-ischemic encephalopathy. This simple method of hypothermia could be used within strict protocols with appropriate training on correct diagnosis and application of hypothermia in nontertiary neonatal settings while awaiting retrieval and transport to the regional neonatal intensive care unit.