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NICHD whole-body cooling trial for birth asphyxia

A trial in US hospitals of the NICHD Neonatal Research Network that compared cooling with usual care in term babies with brain injury after birth asphyxia.

  • Study
  • In this atlas

Overview

Design
Randomised, parallel-group trial of whole-body cooling in infants of at least 36 weeks of gestation with moderate or severe encephalopathy. The paper cooled to an esophageal temperature of 33.5 degrees C for 72 hours, followed by slow rewarming; the registry describes cooling over 96 hours. Registry masking: none.
Phase
Phase 3
Enrolled
  • 208 infants (ClinicalTrials.gov gives no unit for the count) (enrolled count) (Whole-Body Cooling for Birth Asphyxia in Term Infants, retrieved )
Sponsor
Funder
Not recorded
Registry
  • NCT NCT00005772
Started
(Whole-Body Cooling for Birth Asphyxia in Term Infants, retrieved )
Primary completion
(actual) (Whole-Body Cooling for Birth Asphyxia in Term Infants, retrieved )
Completion
(actual) (Whole-Body Cooling for Birth Asphyxia in Term Infants, retrieved )
Countries
United States (Whole-Body Cooling for Birth Asphyxia in Term Infants, retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Randomised, parallel-group trial (ClinicalTrials.gov NCT00005772, phase 3, masking none). The 2005 main report gives 102 infants assigned to cooling and 106 to usual care. The lead sponsor named on the registry is the NICHD Neonatal Research Network.

Arms

  • Whole-body hypothermia

    Intervention Cooling treatment (therapeutic hypothermia) for HIE

    Whole-body cooling to an esophageal temperature of 33.5 degrees C (paper: for 72 hours, then slow rewarming; registry: over 96 hours).

  • Usual care

    Intervention None named

    Control group given usual care (registry: standard care, esophageal temperature at or near 37.0 degrees C).

Findings

No findings are published for this study.

Record details

Record id
maternal:nichd-whole-body-cooling-trial
Content hash
5dc237ea67d41126b34bda78f1414c0f579821d253c7b003ff95ca22bf078be2