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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~up to 18 years of age
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 years of age for reporting.

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 more
Other 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 more

BIPED 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.

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,336 Previous Clinical Trials
25,750,244 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

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03567473 — Phase 3
Bronchiolitis Research Study Groups: Active Intervention Arm, Control Arm
Bronchiolitis Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT03567473 — Phase 3
Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03567473 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Nebulized Epinephrine a long-term solution or does it just act as a temporary fix?

"Nebulized Epinephrine's safety is commonly considered to be a 3 because it has gone through Phase 3 clinical trials."

Answered by AI

Does this research project include patients who are 85 years or older?

"This study is recruiting young infants that are between 2-10 years old."

Answered by AI

Why is Nebulized Epinephrine commonly prescribed?

"Nebulized epinephrine is an effective medication for ophthalmia, sympathetic. Additionally, it can help treat branch retinal vein occlusion, laryngotracheobronchitis, and macular edema."

Answered by AI

To whom does this trial's criteria apply?

"This study seeks 864 participants that are between 2 months old to a year, have bronchiolitis, and meet the following: they must have presented to the emergency department with an episode of bronchiolitis during RSV season (between December and April if in the Northern Hemisphere or June to October if in the Southern Hemisphere) with symptoms such as wheezing, crackles, and an upper respiratory infection like a cough or coryza. Children younger than 60 days or older than 12 months will not be enrolled due to risks associated with glucocorticoid use and other comorbidities."

Answered by AI

Could you inform me as to how many places this experiment is being conducted?

"Out of the 6 total sites, this clinical trial is currently recruiting patients from Sherbrook, Ottawa and London. The other locations are yet to begin recruitment. If you are interested in participating, please choose a clinic close to your residence to avoid travel complications."

Answered by AI

Are Nebulized Epinephrine treatments supported by other research?

"Nebulized Epinephrine was first researched in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. As of now, there have been 1331 completed studies with 607 more currently recruiting participants. A large number of these experiments are being conducted out of Sherbrook in Winnipeg."

Answered by AI
~108 spots leftby Dec 2024