Prone Positioning in Pediatric Acute Lung Injury
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prone Positioning in Pediatric Acute Lung Injury|
- Prone positioning versus supine positioning in determining ventilator-free days in infants and children
|Study Start Date:||August 2001|
|Estimated Study Completion Date:||April 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00133614
|United States, Massachusetts|
|Childrens Hospital, Boston|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Martha Curley, RN,PhD,FAAN||Children's Hospital Boston|