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SUPPORT trial (CPAP against surfactant; oxygen saturation targets)

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.

  • Study
  • In this atlas

Overview

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.
Phase
Phase 3
Enrolled
  • 1,316 infants (enrolled count) (Early CPAP versus surfactant in extremely preterm infants, retrieved )
Sponsor
Funder
Not recorded
Registry
Not reported
Started
(Surfactant Positive Airway Pressure and Pulse Oximetry Trial, retrieved )
Primary completion
(actual) (Surfactant Positive Airway Pressure and Pulse Oximetry Trial, retrieved )
Completion
(actual) (Surfactant Positive Airway Pressure and Pulse Oximetry Trial, retrieved )
Results first posted
(anticipated) (Surfactant Positive Airway Pressure and Pulse Oximetry Trial, retrieved )
Countries
United States (Surfactant Positive Airway Pressure and Pulse Oximetry Trial, retrieved )
Care setting
A multicentre trial; the abstract names no wards and the registry lists United States locations. (Early CPAP versus surfactant in extremely preterm infants, retrieved )
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

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.

Arms

Findings

No findings are published for this study.

Claims and evidence

Context 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
Extremely preterm infants born at 24 weeks 0 days to 27 weeks 6 days of gestation
Gestational age
24 weeks 0 days (168 days) to 27 weeks 6 days (195 days), measured at birth
Postnatal age
Not reported
Follow-up
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: 1 inclusion criterion; exclusion criteria not stated
Included
  • Infants born between 24 weeks 0 days and 27 weeks 6 days of gestation
Excluded
None stated

  • Effect Interventional Certainty not assessed

    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.

    Applies to Newborn
    • 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.
    • A randomised multicentre trial run by the SUPPORT Study Group of the NICHD Neonatal Research Network; the abstracts name no wards.
    • United States (ClinicalTrials.gov locations)
    • Extremely preterm infants born at 24 weeks 0 days to 27 weeks 6 days of gestation
    • Gestational age 24 weeks 0 days to 27 weeks 6 days, measured at birth
    • Postnatal age Not reported
    Follow-up 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.
    Certainty method
    Not assessed
    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.
    Last checked
    2026-10-15
    Next evidence check due
    Not scheduled
    Sources and citations (3)

    1. Supports Target ranges of oxygen saturation in extremely preterm infants

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2010-05-27 · DOI: 10.1056/NEJMoa0911781 · PMID: 20472937 · PMCID: PMC2891970

      Locator
      Abstract, RESULTS sentences 1 to 3 and CONCLUSIONS sentence 2
      How it applies
      Primary composite, deaths and severe retinopathy among survivors.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      49e86c89cc707bccb12261ed2af7a2559c5e2141eb972363bdd146cd88771cd7
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    2. Background Target ranges of oxygen saturation in extremely preterm infants

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2010-05-27 · DOI: 10.1056/NEJMoa0911781 · PMID: 20472937 · PMCID: PMC2891970

      Locator
      Abstract, METHODS sentences 1 and 2
      How it applies
      Target ranges, population and the primary outcome definition.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      49e86c89cc707bccb12261ed2af7a2559c5e2141eb972363bdd146cd88771cd7
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    3. Background Surfactant Positive Airway Pressure and Pulse Oximetry Trial

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2019-04-18. · NCT: NCT00233324

      Locator
      protocolSection.designModule.designInfo.maskingInfo.masking
      How it applies
      Registry masking value.
      Retrieved
      Source effective date
      2019-04-18
      Source state
      Current
      Snapshot hash
      5fdcb0c4642696db1bd7bd6b0c6e5107f70fc1151598abf877d724e89872668a
      Reuse basis
      Registry record. The raw API JSON is committed. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified; any quotation stays short. The raw file is committed at research/snapshots/mn-ctgov-NCT00233324.json.

Record details

Record id
maternal:support-trial
Content hash
c2cdfa1571912e6af4469292a4730d22d264d3c66a3e5292fe63b74968e173e8