• The Journal of pediatrics · Apr 2015

    Randomized Controlled Trial Multicenter Study

    A randomized clinical trial of therapeutic hypothermia mode during transport for neonatal encephalopathy.

    • Vishnu Priya Akula, Priscilla Joe, Kajori Thusu, Alexis S Davis, John S Tamaresis, Sunhwa Kim, Thomas K Shimotake, Stephen Butler, Jose Honold, Michael Kuzniewicz, Glenn DeSandre, Mihoko Bennett, Jeffrey Gould, Matthew B Wallenstein, and Krisa Van Meurs.
    • Division of Neonatal and Developmental Medicine, Department of Pediatrics, Stanford University School of Medicine and Lucile Packard Children's Hospital Stanford, Palo Alto, CA.
    • J. Pediatr. 2015 Apr 1;166(4):856-61.e1-2.

    ObjectiveTo determine if temperature regulation is improved during neonatal transport using a servo-regulated cooling device when compared with standard practice.Study DesignWe 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°-34°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.ResultsOne 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 <.001), and in a shorter time period (44 ± 31 minutes vs 63 ± 37 minutes, P = .04). Device-cooled infants reached target temperature by 1 hour with greater frequency than control infants (71% vs 20%, P < .001).ConclusionsCooling using a servo-regulated device provides more predictable temperature management during neonatal transport than does usual care for outborn newborns with neonatal encephalopathy.Copyright © 2015 Elsevier Inc. All rights reserved.

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