Were There "Additional Foreseeable Risks" in the SUPPORT Study? Lessons Not Learned from the ARDSnet Clinical Trials.

Didier Dreyfuss, Henry J Silverman

Journal: The Hastings Center report 2015;45(1):21-9

PMID: 25530226

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Abstract

Even though the interventions were adapted from standard clinical practice, the way they were provided meant that the care given infants in the study was distinctly different from standard care, with different risk profiles. Parents should have been informed about those differences.

DOI: 10.1002/hast.403

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MeSH Terms: Brain, Brain Injuries, Comparative Effectiveness Research, Ethics Committees, Research, Humans, Infant, Newborn, Infant, Premature, Intensive Care, Neonatal, Intubation, Intratracheal, National Institutes of Health (U.S.), Oximetry, Oxygen, Parental Consent, Positive-Pressure Respiration, Randomized Controlled Trials as Topic, Research Design, Retinopathy of Prematurity, Risk Adjustment, Standard of Care, Surface-Active Agents, Treatment Outcome, Truth Disclosure, United States