{
  "release_id": "fc5a600ec7387e71",
  "id": "maternal:cap-trial",
  "owner": "maternal",
  "kind": "study",
  "slug": "cap-trial",
  "name": "Caffeine for Apnea of Prematurity (CAP) trial",
  "aliases": [],
  "atlases": [
    "maternal"
  ],
  "summary_plain": "A placebo-controlled trial in very low birth weight babies (500 to 1250 g) that compared caffeine with placebo, started in the first 10 days of life and given until treatment for apnoea of prematurity was no longer needed. Short-term results favoured caffeine for the need for oxygen at 36 weeks, with temporarily lower weight gain and no clear difference in death, brain injury on ultrasound or necrotizing enterocolitis.",
  "summary_technical": "Registry NCT00182312 (phase 3, randomised, parallel, masking triple, status COMPLETED, lead sponsor McMaster University) and the 2006 paper (PubMed abstract only). The registry's enrolment of 2000 is an estimate; the abstract reports 2006 infants randomly assigned. The registry's primary outcome is the combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months, which this record does not report; its secondary outcomes include bronchopulmonary dysplasia. Later follow-up papers were not read.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-15",
  "last_evidence_check": "2026-10-15",
  "next_review_due": null,
  "identifiers": [],
  "navigation": {
    "maternal": {
      "life-stage": [
        "newborn",
        "infant-follow-up"
      ],
      "care-area": [
        "preterm-and-sick-newborn"
      ]
    }
  },
  "payload": {
    "design": "Randomised, parallel-group, placebo-controlled trial of caffeine citrate injection in infants of 500 to 1250 g. Registry: allocation randomised, intervention model parallel, masking triple, primary purpose prevention.",
    "drug_phase": "3",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "maternal:ctgov-nct00182312-2026-10-15"
      }
    ],
    "start_date": {
      "date": "1999-10",
      "type": null,
      "snapshot": "maternal:ctgov-nct00182312-2026-10-15"
    },
    "primary_completion_date": {
      "date": "2007-03",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct00182312-2026-10-15"
    },
    "completion_date": {
      "date": "2016-07",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct00182312-2026-10-15"
    },
    "results_first_posted": null,
    "countries": [
      {
        "code": "US",
        "snapshot": "maternal:ctgov-nct00182312-2026-10-15"
      },
      {
        "code": "AU",
        "snapshot": "maternal:ctgov-nct00182312-2026-10-15"
      },
      {
        "code": "CA",
        "snapshot": "maternal:ctgov-nct00182312-2026-10-15"
      },
      {
        "code": "DE",
        "snapshot": "maternal:ctgov-nct00182312-2026-10-15"
      },
      {
        "code": "IL",
        "snapshot": "maternal:ctgov-nct00182312-2026-10-15"
      },
      {
        "code": "NL",
        "snapshot": "maternal:ctgov-nct00182312-2026-10-15"
      },
      {
        "code": "SE",
        "snapshot": "maternal:ctgov-nct00182312-2026-10-15"
      },
      {
        "code": "CH",
        "snapshot": "maternal:ctgov-nct00182312-2026-10-15"
      },
      {
        "code": "GB",
        "snapshot": "maternal:ctgov-nct00182312-2026-10-15"
      }
    ],
    "care_setting": null,
    "stopped_early": null,
    "enrollment": [
      {
        "count": 2000,
        "basis": "planned",
        "unit": "infants (registry estimated enrolment; ClinicalTrials.gov gives no unit)",
        "snapshot": "maternal:ctgov-nct00182312-2026-10-15"
      },
      {
        "count": 2006,
        "basis": "randomized",
        "unit": "infants",
        "snapshot": "maternal:pubmed-16707748-2026-10-15"
      }
    ],
    "arms": [
      {
        "id": "maternal:cap-trial-arm-caffeine",
        "label": "Caffeine",
        "intervention": "maternal:caffeine-citrate",
        "description": "Caffeine until drug therapy for apnoea of prematurity was no longer needed (abstract); the registry names the intervention as caffeine citrate injection."
      },
      {
        "id": "maternal:cap-trial-arm-placebo",
        "label": "Placebo",
        "intervention": null,
        "description": "Matching placebo until drug therapy for apnoea of prematurity was no longer needed (abstract)."
      }
    ],
    "findings": []
  },
  "content_digest": "b42f571bdc6eaa61df58b9985747c9ce425b199d35f577dfb847fd1320706b3a",
  "review": {
    "content_digest": "b42f571bdc6eaa61df58b9985747c9ce425b199d35f577dfb847fd1320706b3a",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Tests caffeine citrate injection",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "maternal:caffeine-citrate",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "maternal:ctgov-nct00182312-2026-10-15",
          "locator": "protocolSection.armsInterventionsModule.interventions[0].name"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/cap-trial/",
  "context_path": "api/v1/context/maternal--cap-trial.md"
}