NCT00133614

Prone Positioning in Pediatric Acute Lung Injury

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (planned)
• Sponsor: National Institute of Nursing Research (NINR) · NIH
• Sex: All
• Age: 2 Weeks – 18 Years
• Healthy volunteers: —

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 description

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.

Conditions

• Acute Lung Injury

Interventions

Type	Name	Description
PROCEDURE	Prone Positioning

Timeline

• Start date: 2001-08-01
• Completion: 2004-04-01
• First posted: 2005-08-23
• Last updated: 2005-10-31

Locations

1 site across 1 country: United States