Single oral dose of dexamethasone in outpatients with bronchiolitis: a placebo controlled trial

Abstract

Background and objectiveThe management of bronchiolitis is still controversial and to the best of our knowledge, no clinical trial with oral corticosteroids in outpatients has been carried out in developing countries. The objective was to compare the efficacy of a single dose of oral dexamethasone in infants with moderate to severe bronchiolitis presenting to an emergency department. Material and MethodsA randomised, double-blind, placebo-controlled trial was conducted in Paraguay. At baseline, respiratory distress assessment instrument (RDAI), heart and respiratory rates, and transcutaneous haemoglobin oxygen saturation (SpO2) were recorded. Children received either a single dose of dexamethasone (0.5mg/kg) or placebo; and then both groups received two nebulisations with adrenaline. Respiratory status was recorded again after the 1st and 4th hours. The primary outcome was RDAI improvement at the 4th hour; and the secondary was the hospital admission rate. ResultsDuring 5 months, 80 (33.3 %) out of 240 infants who consulted with acute respiratory illness fulfilled the inclusion criteria. During the trial 15 were excluded, therefore, 65 infants (33 in the dexamethasone vs. 32 in the placebo group) finished the study. Baseline characteristics and respiratory status were similar between groups. There were no differences in RDAI, heart and respiratory rate and SpO2 between groups after the 1st and 4th hours. The hospitalisation rate was similar between groups (21 % vs. 25 %, p=0.9, respectively), independently of the virus identified. ConclusionsInfants with moderate-severe bronchiolitis who were treated with a single dose of dexamethasone did not significantly alter the rate of hospitalisation or respiratory status.