Clinical trial design—effect of prone positioning on clinical outcomes in infants and children with acute respiratory distress syndrome

Curley, Martha A.Q.; Arnold, John H.; Thompson, John E.; Fackler, James C.; Grant, Mary Jo; Fineman, Lori D.; Cvijanovich, Natalie; Barr, Frederick E.; Molitor-Kirsch, Shirley; Steinhorn, David M.; Matthay, Michael A.; Hibberd, Patricia L.; for the Pediatric Prone Positioning Study Group,

doi:10.1016/j.jcrc.2005.12.004

« Previous Next »Journal of Critical Care
Volume 21, Issue 1 , Pages 23-32, March 2006

Clinical trial design—effect of prone positioning on clinical outcomes in infants and children with acute respiratory distress syndrome☆

Martha A.Q. Curley, RN, PhD, FAAN
- Critical Care and Cardiovascular Nursing, Children's Hospital, Boston, MA 02115, USA
- Corresponding author. Medical-Surgical ICU, Children's Hospital Boston, Boston, MA 02115, USA.
John H. Arnold, MD
- Critical Care and Anesthesiology, Children's Hospital, Boston, MA 02115, USA
John E. Thompson, RRT
- Respiratory Therapy, Children's Hospital, Boston, MA 02115, USA
James C. Fackler, MD
- Johns Hopkins Anesthesiology and Critical Care Medicine, The Johns Hopkins Hospital Baltimore, MD 21287, USA
Mary Jo Grant, RN, PhD
- Critical Care Nursing Research, Primary Children's Medical Center, Salt Lake City, UT 84113, USA
Lori D. Fineman, RN, MSN
- Cardiovascular Critical Care Nursing, University of California, San Francisco, CA 94143, USA
Natalie Cvijanovich, MD
- Division of Critical Care, Children's Hospital Oakland, Oakland, CA 94609, USA
Frederick E. Barr, MD
- Division of Pediatric Critical Care, Department of Pediatrics, Vanderbilt Children's Hospital Nashville, TN 37232-9075, USA
Shirley Molitor-Kirsch, RN, MSN
- Critical Care Nursing, Children's Medical Center of Dallas
David M. Steinhorn, MD
- Pulmonary and Critical Care Medicine, Children's Memorial Hospital, Chicago, IL 60614, USA
Michael A. Matthay, MD
- Critical Care Medicine and Anesthesia, University of California, San Francisco, CA 94143, USA
Patricia L. Hibberd, MD, PhD
- Division of Clinical Research Resources, Tufts-New England Medical Center, Boston, MA 02111, USA
for the Pediatric Prone Positioning Study Group

Abstract

Purpose

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.

Conclusions

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.

Keywords: Clinical trial, Multisite study, Research methods, Acute respiratory distress syndrome (ARDS), Acute lung injury, Prone, Position