A Randomized Controlled Trial Comparing Epinephrine and Dexamethasone to Placebo in the Treatment of Infants with Bronchiolitis
Principal Investigator: Dr. Amy Plint (CHEO)
Project Manager: Tremaine Rowe
We will conduct a phase III multicenter, randomized, trial comparing treatment with nebulized epinephrine and 2-day course of oral dexamethasone to placebo for infants with bronchiolitis.
To determine if treatment of infants presenting with bronchiolitis to the emergency department (ED) with nebulized epinephrine and a 2-day course of oral dexamethasone is effective in reducing the need for hospitalization (due to bronchiolitis) by day 7 compared to placebo.
(1) To determine if treatment of infants presenting with bronchiolitis to the ED with nebulized epinephrine and a 2-day course of oral dexamethasone is effective in reducing hospitalizations (for bronchiolitis) at enrolment ED visit and/or by day 21 compared to placebo.
(2) To determine if there is a difference between groups in all cause hospitalizations by day 7, all cause hospitalizations by day 21, all cause ED visits over 21 days, length of ED visit, length of hospitalization, length of symptoms, and health care-related costs.
Primary Endpoint: Hospitalization due to bronchiolitis by 7 days (168 hours) following enrolment.
(a)Hospitalization due to bronchiolitis at enrolment visit
(b)hospitalization due to bronchiolitis by 21 days following enrolment
(c)all cause hospitalization by day 7
(d)all cause admissions by day 21
(e)all cause ED visits by day 21
(f)length of stay in the ED at enrolment visit for participants discharged at the index visit
(h)length of hospitalization for participants admitted at the enrolment visit
Study Population: We will enroll 1800 infants across Canada at participating sites. We will enroll children > 60 days of age and < 12 months of age presenting with bronchiolitis during the winter viral season. Children born at less than 37-weeks gestation and less than 60 days corrected age and those with known chronic lung disease, congenital heart disease, immunodeficiency, recent exposure to varicella, and those who are critically unwell will not be enrolled in the study.
Phase: Phase III
Description of Sites/Facilities Enrolling Participants: This study will enroll patients at six pediatric academic EDs across Canada. Participating sites are: CHU Ste Justine, Children’s Hospital of Eastern Ontario, Children’s Hospital – London Health Sciences Centre, Health Sciences Centre Winnipeg Children’s Hospital Alberta Children’s Hospital, and Stollery Children’s Hospital. Study sites in New Zealand and Australia will be added if needed to meet our target sample size.
Description of Study Intervention: Two treatments with nebulized epinephrine (3 mL of 1:1000) 30 minutes apart in the ED and two doses of oral dexamethasone (0.6 mg/kg per dose; maximum single dose 10 mg) with the first dose of dexamethasone immediately preceding the first nebulization treatment and the second dose 24 hours later.
Study Duration: Estimated time (in months) from when the study opens to enrolment until completion of data analyses.
Participant Duration: Participants will be followed (by telephone or email survey) for 21 days after their enrolment visit.