{
  "release_id": "c7fb95f1d15a7d13",
  "id": "maternal:helix-trial",
  "owner": "maternal",
  "kind": "study",
  "slug": "helix-trial",
  "name": "HELIX trial (cooling in low- and middle-income countries)",
  "aliases": [],
  "atlases": [
    "maternal"
  ],
  "summary_plain": "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.",
  "summary_technical": "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.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-14",
  "last_evidence_check": null,
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "nct",
      "value": "NCT02387385",
      "normalized_value": "NCT02387385",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "maternal": {
      "life-stage": [
        "newborn"
      ],
      "care-area": [
        "newborn-care"
      ]
    }
  },
  "payload": {
    "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.",
    "drug_phase": "not_applicable",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "maternal:ctgov-nct02387385-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2015-08",
      "type": null,
      "snapshot": "maternal:ctgov-nct02387385-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2020-09-30",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct02387385-2026-10-14"
    },
    "completion_date": {
      "date": "2020-12-01",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct02387385-2026-10-14"
    },
    "results_first_posted": null,
    "countries": [
      {
        "code": "BD",
        "snapshot": "maternal:ctgov-nct02387385-2026-10-14"
      },
      {
        "code": "IN",
        "snapshot": "maternal:ctgov-nct02387385-2026-10-14"
      },
      {
        "code": "LK",
        "snapshot": "maternal:ctgov-nct02387385-2026-10-14"
      }
    ],
    "care_setting": {
      "description": "Seven tertiary neonatal intensive care units with facilities for invasive ventilation, cardiovascular support and 3 Tesla MRI.",
      "snapshot": "maternal:pmc-pmc8371331-2026-10-14"
    },
    "stopped_early": null,
    "enrollment": [
      {
        "count": 408,
        "basis": "enrolled",
        "unit": "infants (ClinicalTrials.gov gives no unit for the count)",
        "snapshot": "maternal:ctgov-nct02387385-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "maternal:helix-trial-arm-cooling",
        "label": "Whole-body hypothermia",
        "intervention": "maternal:therapeutic-hypothermia",
        "description": "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."
      },
      {
        "id": "maternal:helix-trial-arm-control",
        "label": "Usual care",
        "intervention": null,
        "description": "Usual care (control group). 206 infants were assigned."
      }
    ],
    "findings": []
  },
  "content_digest": "6574844265b902386e5e1f196c891835f08a4724d8d3dbad5ebcc058225d3e7b",
  "review": {
    "content_digest": "6574844265b902386e5e1f196c891835f08a4724d8d3dbad5ebcc058225d3e7b",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Tests whole-body cooling",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "maternal:therapeutic-hypothermia",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "maternal:pmc-pmc8371331-2026-10-14",
          "locator": "Abstract, Methods, sentence 3, fragment 1 of 2"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "funded_by",
        "label": "Named among the funders in the abstract",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "maternal:gates-foundation",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "maternal:pmc-pmc8371331-2026-10-14",
          "locator": "Abstract, Funding, sentence 1"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/helix-trial/",
  "context_path": "api/v1/context/maternal--helix-trial.md"
}