Maternal & Newborn Atlas
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HELIX trial (cooling in low- and middle-income countries)

A trial in India, Sri Lanka and Bangladesh that compared cooling with usual care in babies with brain injury after birth. Cooling did not reduce death or disability, and more babies died with cooling.

  • Study
  • In this atlas

Overview

Design
Multicountry open-label randomised controlled trial in seven tertiary neonatal intensive care units. Infants were allocated by a web-based system to whole body hypothermia (33.5 degrees C) for 72 hours with a servo-controlled device, or usual care, within 6 hours of birth. Analysis was by intention to treat; outcome assessors were masked.
Phase
Not applicable
Enrolled
  • 408 infants (ClinicalTrials.gov gives no unit for the count) (enrolled count) (Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial, retrieved )
Sponsor
Not recorded
Funder
Registry
  • NCT NCT02387385
Started
(Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial, retrieved )
Primary completion
(actual) (Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial, retrieved )
Completion
(actual) (Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial, retrieved )
Countries
Bangladesh, India, Sri Lanka (Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial, retrieved )
Care setting
Seven tertiary neonatal intensive care units with facilities for invasive ventilation, cardiovascular support and 3 Tesla MRI. (Hypothermia for moderate or severe neonatal encephalopathy in low-income and middle-income countries (HELIX): a randomised controlled trial in India, Sri Lanka, and Bangladesh, retrieved )
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Open-label randomised trial in seven tertiary neonatal intensive care units (ClinicalTrials.gov NCT02387385; Lancet Global Health 2021). 408 infants were recruited, 202 to cooling and 206 to usual care. Primary outcome data were available for 195 and 199. The authors conclude that cooling should not be offered for neonatal encephalopathy in low-income and middle-income countries, even where tertiary neonatal intensive care facilities are available. The deaths finding is reported as the trial reported it.

Arms

  • Whole-body hypothermia

    Intervention Cooling treatment (therapeutic hypothermia) for HIE

    Whole-body cooling to 33.5 degrees C for 72 hours with a servo-controlled cooling device, within 6 hours of birth. 202 infants were assigned.

  • Usual care

    Intervention None named

    Usual care (control group). 206 infants were assigned.

Findings

No findings are published for this study.

Record details

Record id
maternal:helix-trial
Content hash
6574844265b902386e5e1f196c891835f08a4724d8d3dbad5ebcc058225d3e7b