BI-PED Study

A Randomised Controlled Trial Comparing Epinephrine and Dexamethasone to Placebo in the Treatment of Infants with Bronchiolitis

Bronchiolitis remains a leading cause of infant hospitalisation in both North America and Australasia.  It accounts for a substantial burden of illness and health-related expenditures. The Canadian Bronchiolitis Epinephrine  Steroid Trial (CanBEST) trial, unexpectedly found that infants treated simultaneously with nebulised epinephrine (adrenaline) and dexamethasone had reduced symptoms sufficiently to decrease hospitalisation by one third.  This was an unanticipated finding and the study was not powered to definitively test for synergy between these drugs – hence this remains a controversial finding.

Given the large health care burden of bronchiolitis, preliminary evidence that the combination of epinephrine and dexamethasone can substantially reduce hospitalisations and the divergent current opinion, there is an urgent need for a trial to confirm if combination therapy with epinephrine and dexamethasone is effective.  We are undertaking an international multicentre clinical trial that will compare nebulised epinephrine and two doses of oral dexamethasone (over two days) to nebulised saline and oral placebo. The primary outcome will be admission to hospital up to 7 days following enrolment.  The patient-based outcomes assessed in this trial include hospitalisation rates, symptoms, costs of care, and risk of adverse events which will be of wide interest to caregivers, clinicians, and health care administrators alike.