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Corticosteroid
Epinephrine + Dexamethasone for Bronchiolitis (BIPED Trial)
Phase 3
Recruiting
Led By Amy Plint, MSc, MD
Research Sponsored by Children's Hospital of Eastern Ontario
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presenting to the ED with an episode of bronchiolitis defined as an episode of wheezing or crackles in a child < 12 month of age associated with signs of an upper respiratory tract infection during peak season for RSV bronchiolitis
Age 60 days to less than 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 years of age
Awards & highlights
BIPED Trial Summary
This trial will test whether inhaling epinephrine and taking a 2-day course of dexamethasone reduces the number of hospitalizations for bronchiolitis in infants.
Who is the study for?
This trial is for infants under 12 months old who are experiencing their first episode of bronchiolitis, with symptoms like wheezing or crackles alongside an upper respiratory infection. They must not have severe respiratory distress, known chronic diseases affecting the heart/lungs, recent steroid treatment, a history of adverse reactions to steroids, prior beta-agonist treatment in the ED before enrollment, exposure to chickenpox without immunity, significant prematurity (<37 weeks and <60 days corrected age), or any barriers to follow-up.Check my eligibility
What is being tested?
The study tests if inhaling epinephrine and taking oral dexamethasone reduces hospital admissions within 7 days compared to a placebo. It's a phase III trial where infants at twelve EDs will be randomly assigned double-blindly into two groups: one receiving actual treatments and the other getting placebos (fake treatments).See study design
What are the potential side effects?
Possible side effects from epinephrine may include rapid heartbeat and shakiness; dexamethasone could cause irritability or increased appetite. Placebo treatments should not cause any direct side effects but won't provide active relief from symptoms.
BIPED Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child under 1 year has wheezing or crackles and signs of a cold during RSV season.
Select...
I am between 2 months and less than 1 year old.
BIPED Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 18 years of age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 years of age
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Admission to hospital for bronchiolitis within 7 days post enrollment
Secondary outcome measures
Admission to hospital for bronchiolitis at the time of the enrollment ED visit
All cause Health care provider visits (including ED visits) by day 21 following enrollment ED
All cause admission to Hospital within 21 days following enrollment ED visit
+1 moreOther outcome measures
Exploratory Outcome 10: Health care utilization (including ambulatory visits, ED visits, hospitalization) for respiratory illness
Exploratory Outcome 11: Development of respiratory illnesses
Exploratory Outcome 1: Admission to hospital for bronchiolitis within 21 days following enrollment ED visit
+12 moreBIPED Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Intervention ArmExperimental Treatment3 Interventions
Oral dexamethasone and nebulized epinephrine OR Oral dexamethasone and inhaled epinephrine given by MDI
Group II: Control ArmPlacebo Group3 Interventions
Oral placebo (OraBlendTM in Canada and a compounded oral placebo solution at New Zealand/Australia sites) and nebulized saline.
OR Oral placebo (OraBlendTM in Canada and a compounded oral placebo solution at New Zealand/Australia sites) and inhaled placebo given by MDI.
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Who is running the clinical trial?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,348 Previous Clinical Trials
26,453,761 Total Patients Enrolled
3 Trials studying Bronchiolitis
909 Patients Enrolled for Bronchiolitis
Children's Hospital Research Institute of ManitobaOTHER
6 Previous Clinical Trials
1,949 Total Patients Enrolled
Research ManitobaOTHER
11 Previous Clinical Trials
16,558 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My child was born prematurely and is under 60 days old, adjusted for early birth.You have had a bad reaction to glucocorticoid medications in the past.You have had chickenpox or been in close contact with someone who has had chickenpox, but you have not had it before.I have a long-term illness that could affect my heart or lungs.I have severe breathing problems needing emergency care.I have not taken any corticosteroids in the past week.I have experienced symptoms of apnea before joining this study.My child under 1 year has wheezing or crackles and signs of a cold during RSV season.You have a respiratory distress assessment instrument (RDAI) score of 3 or less.I am between 2 months and less than 1 year old.I have received beta-agonist treatment in the emergency department before joining this study.
Research Study Groups:
This trial has the following groups:- Group 1: Active Intervention Arm
- Group 2: Control Arm
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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