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

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 we

SUBMITTER: Cortes-Puch I 

PROVIDER: S-EPMC4871545 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature