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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Subjects in this group will receive a loading dose of methylprednisolone 2mg/kg followed by 1mg/kg/day of methylprednisolone infusion from day 1 to day 7; 0.5mg/kg/d from days 8 to 10, 0.25mg/kg/d on days 11 and 12, 0.125mg/kg/d on days 13 and 14. The study drug infusion will be discontinued after 14 days.
The placebo will be 0.9% (normal) saline and the active medication will be diluted in 0.9% (normal) saline.
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Duration of mechanical ventilation
Number of hours required for positive pressure ventilation after the start of study drug
Time frame: 0-28 days
Improvement in oxygenation
Differences in the PaO2/FiO2 ratios between the two randomized groups
Time frame: 0-28 days
Incidence of nosocomial infections
Infection surveillance will be in the form of tracheal aspirate for gram stain and culture done prior to study entry and then every 3-5 days. If a subject spikes a fever during the study drug infusion, they will have blood, urine and tracheal aspirate cultures done along with CBC and CRP. Number of nosocomial infections documented via surveillance cultures will be compared between groups.
Time frame: 0-35 days
Incidence of hyperglycemia
Number of times that the subject has a Blood Glucose \>180 mg/dL (10 mmol/L) will be compared between the randomized groups
Time frame: 0-28 days
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