Clinical Trial: Prone Positioning in Pediatric Acute Lung Injury

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prone Positioning in Pediatric Acute Lung Injury

Brief Summary: The purpose of this trial is to test the hypothesis that at the end of 28 days, infants and children with acute lung injury treated with prone positioning would have more ventilator-free days than those treated with supine positioning.

Detailed Summary:

Multicenter, randomized, controlled clinical trial conducted from August 28, 2001 to April 23, 2004, of 102 pediatric patients from 7 US pediatric intensive care units aged 2 weeks to 18 years who were treated with supine vs. prone positioning. Randomization was concealed and group assignment was not blinded.

Patients were randomized to either supine or prone positioning within 48 hours of meeting acute lung injury criteria, with those patients in the prone group being positioned within 4 hours of randomization and remaining prone for 20 hours each day during the acute phase of their illness for a maximum of 7 days, after which they were positioned supine. Both groups were treated using lung protective ventilator and sedation protocols, extubation readiness testing, and hemodynamic, nutrition, and skin care guidelines.

Sponsor: National Institute of Nursing Research (NINR)

Current Primary Outcome: Prone positioning versus supine positioning in determining ventilator-free days in infants and children

Original Primary Outcome: Prone positioning vs. supine positioning in determining ventilator-free days in infants and children

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Institute of Nursing Research (NINR)

Dates:
Date Received: August 19, 2005
Date Started: August 2001
Date Completion: April 2004
Last Updated: October 28, 2005
Last Verified: August 2005