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Epinephrine + Dexamethasone for Bronchiolitis (BIPED Trial)
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.
BIPED Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBIPED Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BIPED Trial Design
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Who is running the clinical trial?
Media Library
- 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.
- Group 1: Active Intervention Arm
- Group 2: Control Arm
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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