Acute Respiratory Distress Syndrome (ARDS) results in significant mortality and morbidity in critically ill children. Despite aggressive treatment. approximately 45% of the 2,500 children afflicted with ARDS each year will die and 15% of survivors will suffer significant impairment in functional status. Prone positioning is a promising therapeutic adjunct to improve gas exchange and, when used early, may improve the clinical course of the patient's acute lung injury (ALI)/ARDS. The purpose of this project is to conduct a multicenter, randomized, non-crossover, controlled clinical trial comparing early, repeated and prolonged prone positioning with supine positioning in children with acute lung injury or acute respiratory distress syndrome. Subjects will include 180 ventilated children with ALI/ARDS. Subjects will be randomly assigned to prone or supine positioning during the acute phase of their ALI/ARDS illness for a maximum of 7 days. After study treatment (prone or supine positioning) all patients who are still intubated will be positioned supine (usual care) until they are successfully extubated or die. Other than positioning, subjects in both groups will be managed in exactly the same way during, the 28-day period. The primary endpoint is ventilator free days during the 28-day period. Secondary end points, include time to recovery of lung injury, organ failure free days, functional outcome, and mortality.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
5R01NR005336-02
Application #
6530952
Study Section
Special Emphasis Panel (ZNR1-REV-A (27))
Program Officer
Bryan, Yvonne E
Project Start
2001-03-01
Project End
2005-02-28
Budget Start
2002-03-01
Budget End
2003-02-28
Support Year
2
Fiscal Year
2002
Total Cost
$552,340
Indirect Cost
Name
Children's Hospital Boston
Department
Type
DUNS #
076593722
City
Boston
State
MA
Country
United States
Zip Code
02115
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