The combined administration of high dose of oral betamethasone and nebulization of adrenaline seems to be an attractive therapeutic alternative for reducing the rate of hospitalization for acute bronchiolitis treated in the emergency department. However, it is essential to confirm the trend previously observed with this treatment before using it in current practice.
Rationale: In infancy, bronchiolitis is the most common acute infection of the lower respiratory tract and is most often caused by the respiratory syncytial virus (RSV). The current treatment of bronchiolitis is controversial. Although meta-analysis of nebulized bronchodilators or corticosteroids treatments failed to show any consistent benefits on admission rate, they remain widely used in pediatric emergency wards. A recent randomized, double-blind, placebo-controlled, clinical trial with a factorial design was conducted to determine whether treatment with nebulized epinephrine, a short course of high dose of oral Betamethasone, or both, resulted in a clinically important decrease in hospital admissions among infants with bronchiolitis who were seen in the emergency department. This study showed that infants in the epinephrine-betamethasone group were significantly less likely than those in the placebo group to be admitted by day 7 (relative risk, 0.65; 95% confidence interval, 0.45 to 0.95, P = 0.02). However, after adjustment for multiple comparisons, this result became insignificant (P = 0.07). This synergistic interaction was not anticipated but gave hope that the association nebulized epinephrine - short course of oral high dose of betamethasone might reduce the risk of hospitalization for infants who consulted pediatric emergencies for a moderate to severe acute bronchiolitis. It is therefore required to conduct a trial dedicated to this evaluation in the French population. Hypothesis: using Epinephrine-Betamethasone allows to reduce the rate of hospitalization of mild-to-severe acute viral bronchiolitis seen in pediatric emergency departments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
195
Placebo: Nebulized 0.9% saline solution
placebo of oral betamethasone: equivalent of 1 mg/kg at inclusion followed by five once-daily doses
Catecholamine nebulized adrenaline (3 ml of 1:1000 solution)
AP-HP, Antoine Béclère Hospital
Clamart, France
Hospital admission up to 7 days after enrollment, which occurred during the visit in the emergency department
determine whether treatment with nebulized adrenaline (3 ml of 1:1000 solution) and a short course of oral dexamethasone (1.0 mg/kg) followed by five once-daily doses (0.6 mg/kg) results in a 10% decrease in hospital admissions among infants with mild-to-severe bronchiolitis seen in emergency departments
Time frame: 7 days after enrollment
PICU admission rate following examination in the emergency ward
Estimate and compare the percentages of infants in each group requiring Pediatric Intensive Care Unit (PICU admission).
Time frame: during the 7 days after enrollment
Length of hospitalization for infants admitted for bronchiolitis in the following 7 days after inclusion
Assess whether experimental treatment reduces healing time and duration of hospitalization of infants included in the study and who have been admitted
Time frame: 7 days after enrollment
Variation of RDAI scores before and after nebulization
Compare clinical scores of respiratory distress before/after treatment
Time frame: between enrollment and an average of 7 days (the end hospitalization)
Adverse events during the following 7 days after inclusion
Evaluate the tolerance of experimental treatment
Time frame: 7 days after enrollment
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Mineralocorticoid: a short course of oral betamethasone: 1.0 mg/kg at inclusion, followed by five once-daily doses (0.6 mg/kg)