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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00133614
Study type Interventional
Source National Institute of Nursing Research (NINR)
Contact
Status Completed
Phase Phase 3
Start date August 2001
Completion date April 2004

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