Journal of critical care
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Journal of critical care · Mar 2006
Randomized Controlled Trial Multicenter StudyClinical trial design--effect of prone positioning on clinical outcomes in infants and children with acute respiratory distress syndrome.
This paper describes the methodology of a clinical trial of prone positioning in pediatric patients with acute lung injury (ALI). Nonrandomized studies suggest that prone positioning improves oxygenation in patients with ALI/acute respiratory distress syndrome without the risk of serious iatrogenic injury. It is not known if these improvements in oxygenation result in improvements in clinical outcomes. A clinical trial was needed to answer this question. ⋯ This paper describes the process, multidisciplinary input, and procedures used to support the design of the clinical trial, as well as the challenges faced by the clinical scientists during the conduct of the clinical trial.