Date of this Version
Journal of Critical Care
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.
Materials and Methods
The pediatric prone study is a multicenter, randomized, noncrossover, controlled clinical trial. The trial is designed to test the hypothesis that at the end of 28 days, children with ALI treated with prone positioning will have more ventilator-free days than children treated with supine positioning. Secondary end points include the time to recovery of lung injury, organ failure–free days, functional outcome, adverse events, and mortality from all causes. Pediatric patients, 42 weeks postconceptual age to 18 years of age, are enrolled within 48 hours of meeting ALI criteria. Patients randomized to the prone group are positioned prone within 4 hours of randomization and remain prone for 20 hours each day during the acute phase of their illness for a maximum of 7 days. Both groups are managed according to ventilator protocol, extubation readiness testing, and sedation protocols and hemodynamic, nutrition, and skin care guidelines.
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.
NOTICE: This is the author’s version of a work that was accepted for publication in Journal of Critical Care. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms, may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. A definitive version was subsequently published in J Crit Care. 2006 March ; 21(1): 23–37. doi:10.1016/j.jcrc.2005.12.004.
Clinical trial, Multisite study, Research methods, Acute respiratory distress syndrome (ARDS), Acute lung injury, Prone, Position
Curley, M. A., Arnold, J. H., Thompson, J. E., Fackler, J. C., Grant, M. C., Fineman, L. D., Cvijanovich, N., Barr, F. E., Molitor-Kirsch, S., Steinhorn, D. M., Matthay, M. A., & Hibberd, P. L. (2006). Clinical Trial Design - Effect of Prone Positioning on Clinical Outcomes in Infants and Children With Acute Respiratory Distress Syndrome. Journal of Critical Care, 21 (1), 23-37. http://dx.doi.org/10.1016/j.jcrc.2005.12.004
Date Posted: 01 June 2016
This document has been peer reviewed.