{
  "release_id": "c7fb95f1d15a7d13",
  "id": "maternal:nichd-whole-body-cooling-trial",
  "owner": "maternal",
  "kind": "study",
  "slug": "nichd-whole-body-cooling-trial",
  "name": "NICHD whole-body cooling trial for birth asphyxia",
  "aliases": [],
  "atlases": [
    "maternal"
  ],
  "summary_plain": "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.",
  "summary_technical": "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.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-14",
  "last_evidence_check": null,
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "nct",
      "value": "NCT00005772",
      "normalized_value": "NCT00005772",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "maternal": {
      "life-stage": [
        "newborn"
      ],
      "care-area": [
        "newborn-care"
      ]
    }
  },
  "payload": {
    "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.",
    "drug_phase": "3",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "maternal:ctgov-nct00005772-2026-10-14"
      }
    ],
    "start_date": {
      "date": "1999-10",
      "type": null,
      "snapshot": "maternal:ctgov-nct00005772-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2003-05",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct00005772-2026-10-14"
    },
    "completion_date": {
      "date": "2010-07",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct00005772-2026-10-14"
    },
    "results_first_posted": null,
    "countries": [
      {
        "code": "US",
        "snapshot": "maternal:ctgov-nct00005772-2026-10-14"
      }
    ],
    "care_setting": null,
    "stopped_early": null,
    "enrollment": [
      {
        "count": 208,
        "basis": "enrolled",
        "unit": "infants (ClinicalTrials.gov gives no unit for the count)",
        "snapshot": "maternal:ctgov-nct00005772-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "maternal:nichd-whole-body-cooling-trial-arm-hypothermia",
        "label": "Whole-body hypothermia",
        "intervention": "maternal:therapeutic-hypothermia",
        "description": "Whole-body cooling to an esophageal temperature of 33.5 degrees C (paper: for 72 hours, then slow rewarming; registry: over 96 hours)."
      },
      {
        "id": "maternal:nichd-whole-body-cooling-trial-arm-control",
        "label": "Usual care",
        "intervention": null,
        "description": "Control group given usual care (registry: standard care, esophageal temperature at or near 37.0 degrees C)."
      }
    ],
    "findings": []
  },
  "content_digest": "5dc237ea67d41126b34bda78f1414c0f579821d253c7b003ff95ca22bf078be2",
  "review": {
    "content_digest": "5dc237ea67d41126b34bda78f1414c0f579821d253c7b003ff95ca22bf078be2",
    "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:ctgov-nct00005772-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.armGroups[0].label"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "results_reported_in",
        "label": "Primary results, NEJM 2005",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "maternal:pub-nichd-cooling-nejm-2005",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "maternal:ctgov-nct00005772-2026-10-14",
          "locator": "protocolSection.referencesModule.references[3].pmid"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "sponsored_by",
        "label": "Lead sponsor named on the registry record",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "maternal:nichd-nrn",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "maternal:ctgov-nct00005772-2026-10-14",
          "locator": "protocolSection.sponsorCollaboratorsModule.leadSponsor.name"
        },
        "primary": false,
        "role": "lead",
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/nichd-whole-body-cooling-trial/",
  "context_path": "api/v1/context/maternal--nichd-whole-body-cooling-trial.md"
}