A randomised controlled trial comparing epinephrine and dexamethasone to placebo in the treatment of infants with bronchiolitis: the Bronchiolitis in Infants Placebo versus Epinephrine and Dexamethasone (BIPED) study protocol.

Abstract

Introduction: Bronchiolitis exerts a significant burden of illness on infants worldwide. National guidelines advise only supportive care. There is evidence that treating infants with bronchiolitis with a combination of inhaled epinephrine and dexamethasone may reduce hospital admissions.

Objective: The aim of this study is to determine if infants with bronchiolitis treated with inhaled epinephrine (delivered by metered dose inhaler with spacer or nebuliser) in the emergency department and a 2-day course of oral dexamethasone have fewer hospitalisations compared to infants treated with placebo.

Methods: The BIPED study (Bronchiolitis in Infants Placebo versus Epinephrine and Dexamethasone) is a randomised, placebo-controlled, observer, investigator, clinician and patient blinded superiority clinical trial being conducted in 12 emergency departments across three countries (Canada, New Zealand and Australia). We will recruit 864 infants between 60 days and 12 months of age with bronchiolitis to receive either: 1) two inhaled epinephrine treatments (3 mg via nebuliser or 625 µg via metered dose inhaler with spacer) 30 min apart and a simultaneous dose of oral dexamethasone (0.6 mg·kg^-1, maximum 10 mg) in the emergency department with the dexamethasone repeated at 24 h; or 2) inhaled placebo and oral placebo. The primary outcome is hospital admission for bronchiolitis within 7 days (168 h) of enrolment. Secondary outcomes include hospital admission during enrolment and all-cause hospital admissions within 21 days of enrolment.

Conclusion: Given the burden of bronchiolitis, there is urgent need for a trial to confirm if combination therapy with epinephrine and dexamethasone is effective.