{
  "release_id": "fc5a600ec7387e71",
  "id": "maternal:support-trial",
  "owner": "maternal",
  "kind": "study",
  "slug": "support-trial",
  "name": "SUPPORT trial (CPAP against surfactant; oxygen saturation targets)",
  "aliases": [],
  "atlases": [
    "maternal"
  ],
  "summary_plain": "A US trial of the Neonatal Research Network in extremely preterm babies, born at 24 weeks 0 days to 27 weeks 6 days. It tested two things at once: starting with CPAP or with a breathing tube and surfactant, and aiming for a lower or a higher blood oxygen level. Neither comparison changed its main result (death or bronchopulmonary dysplasia for the first; severe retinopathy of prematurity or death for the second). With the lower oxygen target more babies died, and fewer survivors had severe retinopathy.",
  "summary_technical": "Registry NCT00233324 (phase 3, randomised, factorial, masking none, completed), with two 2010 papers read as PubMed abstracts: the CPAP paper (PMID 20472939, which has a published erratum that was not read) and the oxygen paper (PMID 20472937). Both abstracts and the registry give 1316 infants. The registry lists the Neonatal Research Network as lead sponsor, and the author list names the SUPPORT Study Group of that network. The registry's two primary outcomes are survival without BPD and survival without severe ROP (threshold disease or the need for surgery); its location countries are recorded.",
  "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"
      ],
      "care-area": [
        "preterm-and-sick-newborn"
      ]
    }
  },
  "payload": {
    "design": "Randomised, multicentre trial with a 2-by-2 factorial design: initial respiratory support (CPAP started in the delivery room against intubation and surfactant within 1 hour of birth) crossed with a target range of oxygen saturation (85 to 89% against 91 to 95%). Registry: allocation randomised, intervention model factorial, masking none, primary purpose treatment.",
    "drug_phase": "3",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "maternal:ctgov-nct00233324-2026-10-15"
      }
    ],
    "start_date": {
      "date": "2005-02",
      "type": null,
      "snapshot": "maternal:ctgov-nct00233324-2026-10-15"
    },
    "primary_completion_date": {
      "date": "2009-02",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct00233324-2026-10-15"
    },
    "completion_date": {
      "date": "2016-08",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct00233324-2026-10-15"
    },
    "results_first_posted": {
      "date": "2014-12-05",
      "type": "anticipated",
      "snapshot": "maternal:ctgov-nct00233324-2026-10-15"
    },
    "countries": [
      {
        "code": "US",
        "snapshot": "maternal:ctgov-nct00233324-2026-10-15"
      }
    ],
    "care_setting": {
      "description": "A multicentre trial; the abstract names no wards and the registry lists United States locations.",
      "snapshot": "maternal:pubmed-20472939-2026-10-15"
    },
    "stopped_early": null,
    "enrollment": [
      {
        "count": 1316,
        "basis": "enrolled",
        "unit": "infants",
        "snapshot": "maternal:pubmed-20472939-2026-10-15"
      }
    ],
    "arms": [
      {
        "id": "maternal:support-trial-arm-surfactant-low-oxygen",
        "label": "Surfactant and low oxygen",
        "intervention": "maternal:pulmonary-surfactants",
        "description": "Surfactant by endotracheal tube and supplemental oxygen with a target saturation of 85% to 89% (registry)."
      },
      {
        "id": "maternal:support-trial-arm-surfactant-high-oxygen",
        "label": "Surfactant and high oxygen",
        "intervention": "maternal:pulmonary-surfactants",
        "description": "Surfactant by endotracheal tube and supplemental oxygen with a target saturation of 91% to 95% (registry)."
      },
      {
        "id": "maternal:support-trial-arm-cpap-low-oxygen",
        "label": "CPAP and low oxygen",
        "intervention": "maternal:nasal-cpap",
        "description": "Continuous positive airway pressure and supplemental oxygen with a target saturation of 85% to 89% (registry)."
      },
      {
        "id": "maternal:support-trial-arm-cpap-high-oxygen",
        "label": "CPAP and high oxygen",
        "intervention": "maternal:nasal-cpap",
        "description": "Continuous positive airway pressure and supplemental oxygen with a target saturation of 91% to 95% (registry)."
      }
    ],
    "findings": []
  },
  "content_digest": "c2cdfa1571912e6af4469292a4730d22d264d3c66a3e5292fe63b74968e173e8",
  "review": {
    "content_digest": "c2cdfa1571912e6af4469292a4730d22d264d3c66a3e5292fe63b74968e173e8",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [
    {
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      "id": "maternal:claim-support-oxygen-targets",
      "owner": "maternal",
      "subject_entity_id": "maternal:support-trial",
      "category": "effect",
      "statement": "In the oxygen-saturation part of SUPPORT, the same infants were randomly assigned to a target range of 85 to 89% or of 91 to 95%. The composite of severe retinopathy of prematurity (threshold disease, surgical eye intervention or bevacizumab) or death before discharge did not differ significantly between the lower and the higher target (28.3% and 32.1%; relative risk with the lower target 0.90; 95% CI 0.76 to 1.06; P=0.21). Death before discharge was more frequent with the lower target (19.9% against 16.2%; relative risk 1.27; 95% CI 1.01 to 1.60; P=0.04), whereas severe retinopathy among survivors was less frequent (8.6% against 17.9%; relative risk 0.52; 95% CI 0.37 to 0.73; P<0.001). There were no significant differences in the rates of other adverse events.",
      "context": {
        "id": "maternal:ctx-support-infants-24-27w",
        "label": "Extremely preterm infants born at 24 weeks 0 days to 27 weeks 6 days (SUPPORT trial)",
        "recipient": "newborn",
        "population": "1316 infants born at 24 weeks 0 days to 27 weeks 6 days of gestation were enrolled. They were randomly assigned both to CPAP or intubation with surfactant and to one of two target ranges of oxygen saturation. The abstract does not describe the infants as having respiratory distress syndrome; entry was by gestational age.",
        "care_setting": "A randomised multicentre trial run by the SUPPORT Study Group of the NICHD Neonatal Research Network; the abstracts name no wards.",
        "geography": "United States (ClinicalTrials.gov locations)",
        "life_stage_note": "Extremely preterm infants born at 24 weeks 0 days to 27 weeks 6 days of gestation",
        "life_stage_terms": {
          "maternal": [
            "newborn"
          ]
        },
        "gestational_age_min_days": 168,
        "gestational_age_max_days": 195,
        "gestational_age_basis": "at_birth",
        "postnatal_age_min_days": null,
        "postnatal_age_max_days": null,
        "gestational_age_status": null,
        "postnatal_age_status": null,
        "followup_description": "The CPAP paper's primary outcome was death or bronchopulmonary dysplasia, defined as the need for supplemental oxygen at 36 weeks (with an attempt at withdrawal of oxygen in infants receiving less than 30% oxygen). The oxygen paper's primary outcome was severe retinopathy of prematurity or death before discharge.",
        "eligibility": {
          "inclusion": [
            "Infants born between 24 weeks 0 days and 27 weeks 6 days of gestation"
          ],
          "exclusion": []
        }
      },
      "evidence_stage": "interventional",
      "certainty": "not_assessed",
      "certainty_method": null,
      "limitations": "Only the abstract was read. Both the benefit (less severe retinopathy among survivors) and the harm (more deaths) are as the authors report them; the authors call the increase in mortality a major concern. The trial was open-label by registry (masking: none) and enrolled infants of 24 weeks 0 days to 27 weeks 6 days only.",
      "editorial_state": "draft",
      "checked_at": "2026-10-15",
      "next_review_due": null,
      "valid_from": null,
      "valid_to": null,
      "citations": [
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          "locator": "Abstract, RESULTS sentences 1 to 3 and CONCLUSIONS sentence 2",
          "applicability_note": "Primary composite, deaths and severe retinopathy among survivors.",
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            "source_effective_date": null,
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            "publication_date": "2010-05-27",
            "publisher": "The New England journal of medicine",
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  "decisions": [],
  "milestones": [],
  "relationships": {
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        "label": "Tests CPAP started in the delivery room",
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}
