Prone Positioning in Pediatric Acute Lung Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00133614|
Recruitment Status : Completed
First Posted : August 23, 2005
Last Update Posted : October 31, 2005
|Condition or disease||Intervention/treatment||Phase|
|Acute Lung Injury||Procedure: Prone Positioning||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prone Positioning in Pediatric Acute Lung Injury|
|Study Start Date :||August 2001|
|Study Completion Date :||April 2004|
- Prone positioning versus supine positioning in determining ventilator-free days in infants and children
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00133614
|United States, Massachusetts|
|Childrens Hospital, Boston|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Martha Curley, RN,PhD,FAAN||Boston Children’s Hospital|