Format

Send to

Choose Destination
See comment in PubMed Commons below
J Pediatr. 2015 Apr;166(4):856-61.e1-2. doi: 10.1016/j.jpeds.2014.12.061. Epub 2015 Feb 12.

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

Author information

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01683383.

PMID:
25684087
DOI:
10.1016/j.jpeds.2014.12.061
[Indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Elsevier Science
    Loading ...
    Support Center