Clinical question: What is the efficacy of dexamethasone in mechanically ventilated children younger than two years of age with respiratory syncytial virus (RSV) lower respiratory tract infections?
Background: Although RSV typically causes self-limited respiratory tract disease with stable and low mortality rates, a small proportion of infants will have severe lower respiratory tract disease requiring mechanical ventilation. The authors previously found no evidence of a benefit of corticosteroids in these infants, but post-hoc analysis suggested a benefit in infants with mild oxygenation abnormalities.
Study design: International, multicenter, randomized, double-blind, placebo-controlled trial.
Setting: Twelve ICUs in Europe.
Synopsis: All patients <2 years of age with RSV-positive bronchiolitis requiring mechanical ventilation were eligible if they had not received corticosteroids in the previous two weeks. Patients were categorized as having either mild or severe oxygenation abnormalities based on their arterial partial pressure of oxygen/fractional inspired oxygen concentration and/or mean airway pressure. The primary outcome measure was duration of mechanical ventilation, and the trial was stopped after interim analysis of 89 patients in the mild oxygenation abnormalities arm revealed insufficient power to detect a >20% difference between the groups if the planned number of 128 patients were ultimately enrolled.
Fifty-six patients were enrolled in the severe oxygenation abnormalities arm. For both groups, there were no differences in either the duration of mechanical ventilation or secondary outcomes, such as length of stay or duration of supplemental oxygen, between intervention and control patients.
This well-designed study adds to an established body of literature painting a clear picture of the inefficacy of corticosteroids in infants with bronchiolitis, with or without severe disease. Although enrollment was slow and ultimately the trial was prematurely terminated, the randomization resulted in almost perfectly matched groups, which likely strengthens the findings despite the small sample size.
Bottom line: Corticosteroids should not be administered to critically ill children with bronchiolitis.
Citation: Van Woensel JB, Vyas H, et al. Dexamethasone in children mechanically ventilated for lower respiratory tract infection caused by respiratory syncytial virus: a randomized controlled trial. Crit Care Med. 2011;39(7):1779-1783.
Reviewed by Pediatric Editor Mark Shen, MD, FHM, medical director of hospital medicine at Dell Children’s Medical Center, Austin, Texas.