Vishnu Priya Akula1, Priscilla Joe2, Kajori Thusu3, Alexis S Davis4, John S Tamaresis5, Sunhwa Kim6, Thomas K Shimotake7, Stephen Butler8, Jose Honold9, Michael Kuzniewicz10, Glenn DeSandre11, Mihoko Bennett12, Jeffrey Gould13, Matthew B Wallenstein1, Krisa Van Meurs1. 1. Division of Neonatal and Developmental Medicine, Department of Pediatrics, Stanford University School of Medicine and Lucile Packard Children's Hospital Stanford, Palo Alto, CA. 2. Division of Neonatology, Children's Hospital and Research Center, Oakland, CA. 3. Division of Neonatology, Children's Hospital Central California, Madera, CA. 4. Pediatrix Medical Group, San Jose, CA. 5. Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA. 6. Division of Neonatology, Loma Linda University Children's Hospital, Loma Linda, CA. 7. Division of Neonatology, University of California San Francisco (UCSF) Medical Center, San Francisco, CA. 8. Division of Neonatology, Sutter Medical Center, Sacramento, CA. 9. Division of Neonatology, Rady Children's Hospital, San Diego, CA. 10. Division of Neonatology, Kaiser Permanente, Oakland, CA. 11. Division of Neonatology, Santa Clara Valley Medical Center, San Jose, CA. 12. California Perinatal Quality Care Collaborative (CPQCC), Palo Alto, CA. 13. Division of Neonatal and Developmental Medicine, Department of Pediatrics, Stanford University School of Medicine and Lucile Packard Children's Hospital Stanford, Palo Alto, CA; California Perinatal Quality Care Collaborative (CPQCC), Palo Alto, CA.
Abstract
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°-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. 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 <.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). CONCLUSIONS: Cooling using a servo-regulated device provides more predictable temperature management during neonatal transport than does usual care for outborn newborns with neonatal encephalopathy.
RCT Entities:
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°-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. 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 <.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). CONCLUSIONS: Cooling using a servo-regulated device provides more predictable temperature management during neonatal transport than does usual care for outborn newborns with neonatal encephalopathy.
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