Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133614
Status:
COMPLETED
Last Update Posted:
2005-10-30
First Post:
2005-08-19
Brief Title:
Prone Positioning in Pediatric Acute Lung Injury
Sponsor:
National Institute of Nursing Research NINR
Organization:
National Institute of Nursing Research NINR
Study Overview
Official Title:
Prone Positioning in Pediatric Acute Lung Injury
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01NR005336-04 | NIH | None | httpsreporternihgovquickSearch5R01NR005336-04 |