title: A randomized clinical trial of therapeutic hypothermia mode during transport for neonatal encephalopathy.
abstract: OBJECTIVE
  To determine if temperature regulation is improved during neonatal transport using a servo-regulated cooling device when compared with standard practice.
  
  
  METHODS
  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.
authors: Division of Neonatal and Developmental Medicine, Department of Pediatrics, Stanford University School of Medicine and Lucile Packard Children's Hospital Stanford, Palo Alto, CA.
authors: Vishnu Priya
authors: VP
authors: Akula
authors: Division of Neonatology, Children's Hospital and Research Center, Oakland, CA.
authors: Priscilla
authors: P
authors: Joe
authors: Division of Neonatology, Children's Hospital Central California, Madera, CA.
authors: Kajori
authors: K
authors: Thusu
authors: Pediatrix Medical Group, San Jose, CA.
authors: Alexis S
authors: AS
authors: Davis
authors: Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA.
authors: John S
authors: JS
authors: Tamaresis
authors: Division of Neonatology, Loma Linda University Children's Hospital, Loma Linda, CA.
authors: Sunhwa
authors: S
authors: Kim
authors: Division of Neonatology, University of California San Francisco (UCSF) Medical Center, San Francisco, CA.
authors: Thomas K
authors: TK
authors: Shimotake
authors: Division of Neonatology, Sutter Medical Center, Sacramento, CA.
authors: Stephen
authors: S
authors: Butler
authors: Division of Neonatology, Rady Children's Hospital, San Diego, CA.
authors: Jose
authors: J
authors: Honold
authors: Division of Neonatology, Kaiser Permanente, Oakland, CA.
authors: Michael
authors: M
authors: Kuzniewicz
authors: Division of Neonatology, Santa Clara Valley Medical Center, San Jose, CA.
authors: Glenn
authors: G
authors: DeSandre
authors: California Perinatal Quality Care Collaborative (CPQCC), Palo Alto, CA.
authors: Mihoko
authors: M
authors: Bennett
authors: 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.
authors: Jeffrey
authors: J
authors: Gould
authors: Division of Neonatal and Developmental Medicine, Department of Pediatrics, Stanford University School of Medicine and Lucile Packard Children's Hospital Stanford, Palo Alto, CA.
authors: Matthew B
authors: MB
authors: Wallenstein
authors: Division of Neonatal and Developmental Medicine, Department of Pediatrics, Stanford University School of Medicine and Lucile Packard Children's Hospital Stanford, Palo Alto, CA.
authors: Krisa
authors: K
authors: Van Meurs
mesh_terms: D001238:Asphyxia Neonatorum / Q000150:complications* / Q000628:therapy; D001831:Body Temperature / Q000502:physiology*; D001927:Brain Diseases / Q000209:etiology / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007036:Hypothermia, Induced / Q000379:methods*; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000628:therapy*; D007363:Intensive Care Units, Neonatal; D008297:Male; D011379:Prognosis; D014187:Transportation of Patients / Q000379:methods*