# HELIX trial (cooling in low- and middle-income countries)

Study · id `maternal:helix-trial` · Maternal & Newborn Atlas · release `c7fb95f1d15a7d13` (public)

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Browse, life stage: Newborn  
Browse, care area: Newborn care  

## In plain language

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.

## 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.

## Key facts

- 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, snapshot `maternal:ctgov-nct02387385-2026-10-14`, retrieved 2026-10-14)
- Started: 2015-08 (Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial, snapshot `maternal:ctgov-nct02387385-2026-10-14`, retrieved 2026-10-14)
- Primary completion: 2020-09-30 (actual) (Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial, snapshot `maternal:ctgov-nct02387385-2026-10-14`, retrieved 2026-10-14)
- Completion: 2020-12-01 (actual) (Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial, snapshot `maternal:ctgov-nct02387385-2026-10-14`, retrieved 2026-10-14)
- Countries: Bangladesh; India; Sri Lanka (Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial, snapshot `maternal:ctgov-nct02387385-2026-10-14`, retrieved 2026-10-14)
- 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, snapshot `maternal:pmc-pmc8371331-2026-10-14`, retrieved 2026-10-14)
- Registry status: "COMPLETED" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `maternal:ctgov-nct02387385-2026-10-14`, retrieved 2026-10-14)

## Connected pages

- Tests whole-body cooling: Cooling treatment (therapeutic hypothermia) for HIE (`maternal:therapeutic-hypothermia`)
- Named among the funders in the abstract: Bill & Melinda Gates Foundation (`maternal:gates-foundation`)

## Provenance

Content hash: 6574844265b902386e5e1f196c891835f08a4724d8d3dbad5ebcc058225d3e7b
Last substantive edit: 2026-10-14
Evidence last checked: Not recorded