A Randomized Clinical Trial of Therapeutic Hypothermia Mode during Transport for Neonatal Encephalopathy
A Randomized Clinical Trial of Therapeutic Hypothermia Mode during Transport for Neonatal Encephalopathy
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DOI：
10.1016/j.jpeds.2014.12.061
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发表时间：
2015-04-01
影响因子：
5.1
通讯作者：
Van Meurs, Krisa
中科院分区：
文献类型：
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作者：
Akula, Vishnu Priya;Joe, Priscilla;Van Meurs, Krisa
目的为了确定是否温度调节是改善新生儿运输过程中使用伺服调节冷却装置相比，与标准practice.Study设计我们进行了一项多中心，随机，非盲临床试验，新生儿脑病冷却运输过程中9新生儿重症监护病房在加州。符合低温治疗机构标准的新生儿被随机分配接受冷却，根据通常的中心实践与设备伺服调节冷却。主要结果是运输过程中温度在目标范围（33摄氏度-34摄氏度）内的百分比。次要结果包括新生儿在运输过程中任何时间达到目标温度的百分比，达到目标温度的时间，以及冷却开始后1小时内新生儿在目标范围内的百分比。对照组49例，器械组51例。基线人口统计学数据除脐带pH值外无差异。对于每例受试者，计算目标范围内温度的百分比。与对照组婴儿相比，使用该装置冷却的婴儿的温度在目标范围内的百分比更高（中位数73% [IQR 17-88] vs 0% [IQR 0-52]，P < .001）。更多的受试者在使用伺服调节装置的运输过程中达到目标温度（80%对49%，P
Objective To determine if temperature regulation is improved during neonatal transport using a servo-regulated cooling device when compared with standard practice.Study design We performed a multicenter, randomized, nonmasked clinical trial in newborns with neonatal encephalopathy cooled during transport to 9 neonatal intensive care units in California. Newborns who met institutional criteria for therapeutic hypothermia were randomly assigned to receive cooling according to usual center practices vs device servo-regulated cooling. The primary outcome was the percentage of temperatures in target range (33 degrees-34 degrees C) during transport. Secondary outcomes included percentage of newborns reaching target temperature any time during transport, time to target temperature, and percentage of newborns in target range 1 hour after cooling initiation.Results One hundred newborns were enrolled: 49 to control arm and 51 to device arm. Baseline demographics did not differ with the exception of cord pH. For each subject, the percentage of temperatures in the target range was calculated. Infants cooled using the device had a higher percentage of temperatures in target range compared with control infants (median 73% [IQR 17-88] vs 0% [IQR 0-52], P < .001). More subjects reached target temperature during transport using the servo-regulated device (80% vs 49%, P