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Usual Care and Informed Consent in Clinical Trials of Oxygen Management in Extremely Premature Infants

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  • Irene Cortés-Puch
  • Robert A Wesley
  • Michael A Carome
  • Robert L Danner
  • Sidney M Wolfe
  • Charles Natanson

Abstract

Objective: The adequacy of informed consent in the Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPORT) has been questioned. SUPPORT investigators and publishing editors, heads of government study funding agencies, and many ethicists have argued that informed consent was adequate because the two oxygen saturation target ranges studied fell within a range commonly recommended in guidelines. We sought to determine whether each oxygen target as studied in SUPPORT and four similar randomized controlled trials (RCTs) was consistent with usual care. Design/Participants/Setting: PubMed, EMBASE, Web of Science, and Scopus were searched for English articles back to 1990 providing information on usual care oxygen management in extremely premature infants. Data were extracted on intended and achieved oxygen saturation levels as determined by pulse oximetry. Twenty-two SUPPORT consent forms were examined for statements about oxygen interventions. Results: While the high oxygen saturation target range (91 to 95%) was consistent with usual care, the low range (85 to 89%) was not used outside of the SUPPORT trial according to surveys and clinical studies of usual care. During usual care, similar lower limits (

Suggested Citation

  • Irene Cortés-Puch & Robert A Wesley & Michael A Carome & Robert L Danner & Sidney M Wolfe & Charles Natanson, 2016. "Usual Care and Informed Consent in Clinical Trials of Oxygen Management in Extremely Premature Infants," PLOS ONE, Public Library of Science, vol. 11(5), pages 1-17, May.
    • Handle: RePEc:plo:pone00:0155005
    DOI: 10.1371/journal.pone.0155005
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