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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03567473




Registration number
NCT03567473
Ethics application status
Date submitted
13/06/2018
Date registered
13/06/2018
Date last updated
25/01/2019

Titles & IDs
Public title
Bronchiolitis in Infants Placebo Versus Dexamethasone Study
Scientific title
A Randomized Controlled Trial Comparing Epinephrine and Dexamethasone to Placebo in the Treatment of Infants With Bronchiolitis
Secondary ID [1] 0 0
CTO 1423
Universal Trial Number (UTN)
Trial acronym
BIPED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiolitis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Oral dexamethasone
Treatment: Drugs - Nebulized Epinephrine
Treatment: Drugs - Oral placebo
Treatment: Drugs - Nebulized normal saline

Experimental: Active Intervention Arm - Oral dexamethasone and nebulized epinephrine

Placebo Comparator: Control Arm - Oral placebo (OraBlendTM in Canada and a compounded oral placebo solution at New Zealand/Australia sites) and nebulized saline.


Treatment: Drugs: Oral dexamethasone
Two doses of oral dexamethasone, 0.6 mg/kg (maximum single dose 10 mg). One at the time of emergency department enrolment immediately prior to first nebulized treatment and one at approximately 24 hour later

Treatment: Drugs: Nebulized Epinephrine
Two nebulized treatments of 3 mL 1:1000 epinephrine 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment

Treatment: Drugs: Oral placebo
Two doses of oral placebo, 0.6 mL/kg (maximum single dose 10 mL). One at the time of emergency department enrolment immediately prior to nebulized treatment and one at approximately 24 hour later . Oral placebo at Canadian sites is composed of OraBlendTM and in New Zealand and Australian sites will be a compounded solution.

Treatment: Drugs: Nebulized normal saline
Two nebulized treatments of 3 mL of normal saline 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Admission to hospital for bronchiolitis within 7 days post enrollment - A physician writing "admit to ward" orders or similar language, or 2) an ED length of stay 12 hours or greater or 3) a combined ED and observation unit stay of 12 hours or greater.
Timepoint [1] 0 0
7 days post enrollment
Secondary outcome [1] 0 0
Admission to hospital for bronchiolitis at the time of the enrollment ED visit - A physician writing "admit to ward" orders or similar language, or 2) an ED length of stay 12 hours or greater or 3) a combined ED and observation unit stay of 12 hours or greater.
Timepoint [1] 0 0
Enrollment visit
Secondary outcome [2] 0 0
All cause admission to Hospital within 21 days following enrollment ED visit - A physician writing "admit to ward" orders or similar language, or 2) an ED length of stay 12 hours or greater or 3) a combined ED and observation unit stay of 12 hours or greater.
Timepoint [2] 0 0
up to 21 days post enrollment
Secondary outcome [3] 0 0
All cause Health care provider visits (including ED visits) by day 21 following enrollment ED
Timepoint [3] 0 0
up to 21 days post enrollment
Secondary outcome [4] 0 0
Health Care related costs within the 21 days following enrollment ED visits. - Health care related costs
Timepoint [4] 0 0
up to 21 days post enrollment

Eligibility
Key inclusion criteria
1. Presenting to the ED with an episode of bronchiolitis. Bronchiolitis will be defined
as an episode of wheezing or crackles in a child < 12 month of age associated with
signs of an upper respiratory tract infection (e.g. cough, coryza, nasal congestion)
during the period deemed to be peak season for RSV bronchiolitis (approximately
December to April in Northern Hemisphere and June to October in Southern Hemisphere).
We have chosen not to define bronchiolitis as the first episode of wheezing or
crackles to better reflect the clinical guidelines and clinical practice
internationally.

2. Age 60 days to less than 12 months. Children younger than 60 days will not be enrolled
due to the risk of concomitant infection and other issues pertaining to glucocorticoid
use in the very young. Children older than 12 months will not be enrolled to minimize
the risk of enrolling children with asthma.
Minimum age
60 Days
Maximum age
12 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Respiratory distress assessment instrument (RDAI) score of less than or equal to 3.
This RDAI will ensure children with very mild respiratory diseases are not enrolled.
This is the lower limit of the RDAI range used in CanBEST.

2. Previously known chronic disease that may affect cardiopulmonary status of the
patient, such as bronchopulmonary dysplasia currently receiving oxygen, cystic
fibrosis, congenital heart disease and immune deficiency. These children may be at
higher risk for developing severe illness.

3. Severe respiratory distress evidenced by a sustained pulse rate > 200 beats/min, a
sustained respiratory rate > 80 breaths/min, profound lethargy (as deemed by the
treating physician), or requiring resuscitation room care. We will exclude these
children as they are likely to be admitted due to severity of illness.

4. Presenting with symptoms of apnea prior to enrollment.

5. Treatment with oral, inhaled, or IV corticosteroids within the last 1 week.

6. History of adverse reaction to glucocorticoids.

7. Treatment with any beta-agonists (salbutamol/albuterol or epinephrine/adrenaline) in
the ED prior to study enrolment.

8. Presence of varicella or recent (less than 3 weeks) close contact (defined as any
household or daycare contact, or greater than 15 minutes of face to face contact, or
greater than 1 hour of being in the same dwelling with an individual) without a
history of prior infection. These patients are not enrolled to reduce any risk of
developing severe varicella with corticosteroid use.

9. Insurmountable language barrier (patient's parent/guardian is unable to understand
English or French to give informed consent and participate in follow-up).

10. Any child born at less than 37weeks gestation who is younger than 60 days corrected
age. We will not enroll these children to lower any risk of exposing young infants to
corticosteroids.

11. Previous enrolment in the trial.

12. Unavailability for follow-up period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Women and Children's Hospital - Adelaide
Recruitment hospital [2] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [3] 0 0
Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
5006 - Adelaide
Recruitment postcode(s) [2] 0 0
3168 - Melbourne
Recruitment postcode(s) [3] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
Canada
State/province [4] 0 0
Winnipeg
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland
Country [6] 0 0
New Zealand
State/province [6] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Hospital of Eastern Ontario
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Children's Hospital Research Institute of Manitoba
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Research Manitoba
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Women and Children's Health Research Institute, Univesrity of Alberta
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Alberta Children's Hospital Research Institute
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
The Hospital for Sick Children
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Department of Pediatrics, Western University
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
St. Justine's Hospital
Address [8] 0 0
Country [8] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
We hypothesize that infants with bronchiolitis treated with nebulized epinephrine in the
Emergency Department (ED) and a 2-day course of oral dexamethasone will have fewer
hospitalizations over 7 days compared to infants treated with placebo. To examine this
hypothesis, we will conduct a phase III, multicentre, randomized, double-blind trial. Infants
presenting to one of six study EDs will be enrolled to one of two study groups: (1) nebulized
epinephrine and oral dexamethasone or (2) nebulized normal saline and oral placebo. Our
primary outcome will be admission for bronchiolitis by day 7 following the enrolment. As a
planned secondary analysis, a between-group comparison of the primary outcome will be
performed in those patients presenting with a first episode of bronchiolitis.
Trial website
https://clinicaltrials.gov/show/NCT03567473
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amy Plint, MSc, MD
Address 0 0
Childrens Hospital of Eastern Ontario (CHEO)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tremaine T Rowe
Address 0 0
Country 0 0
Phone 0 0
613-737-7600
Fax 0 0
Email 0 0
trowe@cheo.on.ca
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable