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Published on: November 4, 2010
Single oral dose of dexamethasone in outpatients with bronchiolitis: a placebo controlled trial
Mirta Mesquita1, Jose A Castro-Rodríguez, Lizzette Heinichen
1Hospital General Pediátrico Niños de Acosta Nú, Asunción, Paraguay. jacastro17@hotmail.com
Insights
A single dose of oral dexamethasone did not improve respiratory status or reduce hospitalizations in infants with moderate to severe bronchiolitis. This study investigated its efficacy in a developing country setting.
Area of Science:
- Pediatrics
- Infectious Diseases
- Clinical Pharmacology
Background:
- Bronchiolitis management remains controversial, with limited research on oral corticosteroid efficacy in developing nations.
- No prior clinical trials have evaluated oral corticosteroids for outpatient bronchiolitis in developing countries.
Purpose of the Study:
- To assess the effectiveness of a single oral dexamethasone dose in infants with moderate to severe bronchiolitis presenting to an emergency department.
- To compare clinical outcomes between dexamethasone and placebo groups.
Main Methods:
- A randomized, double-blind, placebo-controlled trial was conducted in Paraguay.
- Infants received either dexamethasone (0.5 mg/kg) or placebo, followed by adrenaline nebulizations.
- Respiratory status was evaluated using the Respiratory Distress Assessment Instrument (RDAI) and vital signs at baseline and 4 hours.
Main Results:
- Sixty-five infants completed the study; baseline characteristics were similar between groups.
- No significant differences were observed in RDAI scores, heart rate, respiratory rate, or oxygen saturation between the dexamethasone and placebo groups at 4 hours.
- Hospitalization rates were comparable: 21% in the dexamethasone group versus 25% in the placebo group (p=0.9).
Conclusions:
- A single dose of oral dexamethasone did not significantly improve respiratory status in infants with moderate to severe bronchiolitis.
- The treatment did not alter the hospital admission rate compared to placebo.
- Findings suggest dexamethasone is not effective for this condition in the studied population.
Background And Objective:
The 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 Methods:
A 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 (SpO(2)) were recorded. Children received either a single dose of dexamethasone (0.5 mg/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.
Results:
During 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 SpO(2) 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.
Conclusions:
Infants with moderate-severe bronchiolitis who were treated with a single dose of dexamethasone did not significantly alter the rate of hospitalisation or respiratory status.
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