Acute Respiratory Distress Syndrome (ARDS) Clinical Trial
Official title:
Steroids in Pediatric Acute Lung Injury/ARDS Trial: A Blinded, Placebo-controlled, Randomized Clinical Trial
Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are devastating
disorders associated with lung inflammation, low oxygen levels and respiratory failure in
children. Prevalence of ALI ranges from 2.2 to 12 per 100,000 children per year. Using these
estimates, up to 9,000 children each year will develop ALI/ARDS, which may cause upto 2,000
deaths per year. Currently, there are no specific therapies directed against ARDS/ALI in
children. In adult patients, use of steroids early in the course of ARDS appears promising.
There are no published clinical trials examining the use of steroids for the treatment of
ALI/ARDS in children.
Hypothesis:
Subjects with ALI/ARDS receiving steroids early in the course of disease (within 72 hours)
and longer than 7 days will have improved clinical outcomes as compared to placebo control
group as defined by (a) a decreased duration of mechanical ventilation and (b) significantly
increased PaO2/FiO2 ratios.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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