CroupPhase 3NCT06272383
Croup Dosing Study
A Phase 3 study testing 0.15 mg/kg dexamethasone in people with Croup, run by University of Manitoba at 1 site in Canada.
Trial summary
Croup is a common childhood respiratory disease that often leads to frequent emergency department visits. It is a viral infection that causes cough, throat, and airway swelling, making breathing difficult. Dexamethasone is a medication that helps to reduce swelling, making breathing easier for children. Read more about this study
- Who is it for?
- Ages 6 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Croup
- What is being tested?
- 0.15 mg/kg dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jun 2024to 20 Feb 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged with clinical diagnosis of croup
Who cannot join
- Children who are unable to tolerate or ingest oral dexamethasone,
- Known hypersensitivity/allergy to dexamethasone,
- Other causes of stridor (such as acute epiglottitis, bacterial tracheitis, anaphylaxis, foreign body aspiration),
- Other underlying systemic diseases defined as chronic lung disease, chronic heart disease, chronic kidney disease, and immunodeficiency),
- Recent exposure to varicella,
- Treatment with oral or intravenous corticosteroids within the preceding 72 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using a Single Dose of Dexamethasone at 0.6mg/kg of Body Weight Versus 0.15 mg/kg of Body Weight for the Treatment of Croup: an Internal Vanguard Randomized Controlled Non-Inferiority Trial.
Croup is a common childhood respiratory disease that often leads to frequent emergency department visits. It is a viral infection that causes cough, throat, and airway swelling, making breathing difficult. Dexamethasone is a medication that helps to reduce swelling, making breathing easier for children. A standard dose of 0.6mg/kg is used in children. However, a lower amount (due to side effects of steroids in children) has been suggested. We will examine whether 25% less than the standard dose is equally effective in treating croup. Investigators will conduct a clinical study with the support of patients with lived experience (which, in this case, are the parents of the children) to better care for children with croup. If proven, this study can improve the outcome in children with croup.
Read the detailed description
Croup is a common childhood respiratory disease that leads to frequent emergency department (ED) visits. It accounts for 7% and 3% of hospitalization in under 5 and children between 6 months-3 years in North America, respectively. It is a self-limiting viral infection characterized by the sudden onset of a seal-like barking cough, often accompanied by stridor, voice hoarseness, and respiratory distress. Glucocorticoids are a class of corticosteroids with anti-inflammatory properties that help alleviate croup symptoms. While dexamethasone (a type of glucocorticoid) is commonly used to treat croup at 0.6mg/kg, a low dose of 0.15mg/kg (due to adverse events (AEs)) has been suggested to be equally effective. Investigators propose an innovative and multidisciplinary approach to investigate the noninferiority of dexamethasone at 0.15mg/kg versus 0.6mg/kg to treat croup.
- Conditions
- Croup
- Being tested
- 0.15 mg/kg dexamethasone
- Keywords
- Croup, Dexamethasone, Bayesian elicitation, Dosing study, Patient engagement
- Medical subject headings
- Croup, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.15 mg/kg dexamethasoneDrug
25% less than the standard practice of dexamethasone at 0.6mg/kg
| Study group | Role | What they receive |
|---|---|---|
| 0.15mg/kg dexamethasone | Experimental | Treatment with one dose of oral dexamethasone (0.15 mg/kg per dose; maximum single dose 3 mg) Receives: Drug: 0.15 mg/kg dexamethasone |
| Standard practice of 0.6mg/kg dexamethasone | Active comparator | Treatment with one dose of oral dexamethasone (0.6 mg/kg per dose; maximum single dose 12 mg) Receives: Drug: 0.15 mg/kg dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return Visits or Readmissions to the Hospital
Return visits or readmissions to the hospital within 7 days following initial presentation to the ED with croup.
Measured: Seven days following initial presentation to the ED with croup.
Secondary outcomes (1)
Adverse Events
Adverse events following treatment with either of the 2 doses of dexamethasone. AEs: Disseminated varicella, gastrointestinal bleeding, unspecified bleeding, pneumonia, sepsis, febrile convulsion, bacteria tracheitis, tachycardia/fast heartbeat, and restlessness.
Measured: within 7 and 30 days of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start5 Jun 2024
- Primary completion28 Jan 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CroupStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an internal double-blinded vanguard randomized controlled trial (RCT), which will be conducted at the Winnipeg Children's Hospital (WCH). Computerized randomization will be performed by a statistician at the George and Fay Yee Centre for HealthCare Innovation to generate the randomization list. Investigators will perform a computerized randomization stratified by age. Investigators will do a block randomization with random blocks of undisclosed block sizes over the seasons to ensure temporal distribution of croup cases is captured. Investigators will randomly assign patients to either the intervention or control in ratio 1:1. While croup is common between 6 months and 5 years, a typical croup affects children between 6 months and 3 years. Based on this, we will randomize such that this age category (6 months-3years) has almost similar distribution in each arm.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex Aregbesola, MD, PhD, Principal investigator, University of ManitobaTerry Klassen, MD, MSc, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272383
- Sponsor's protocol ID
- HS26166 (B2023:092)
- Status last verified
- Jul 2025
- First submitted
- 15 Feb 2024
- Last updated
- 8 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang A, Aregbesola A, Gangwani A, Klassen TP, Plint AC, Doyle E, Craig W, Eltorki M, Oketola B, Badran H, Ouyang Y, Heath A. Remote, bivariate prior elicitation for a Bayesian non-inferiority randomized controlled trial. Trials. 2026 Jun 5. doi: 10.1186/s13063-026-09828-8. Online ahead of print.
PubMed 42249465
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Single Dose of Dexamethasone at 0.6mg/kg of Body Weight Versus 0.15 mg/kg of Body Weight for the Treatment of Croup: an Internal Vanguard Randomized Controlled Non-Inferiority Trial.
- ClinicalTrials.gov ID
- NCT06272383
- Acronym / sponsor ID
- HS26166 (B2023:092)
- Conditions
- Croup
- Keywords
- Croup, Dexamethasone, Bayesian elicitation, Dosing study, Patient engagement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 28 Jan 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 22 Feb 2024 (actual)
- Results
- Posted 8 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Croup is a common childhood respiratory disease that often leads to frequent emergency department visits. It is a viral infection that causes cough, throat, and airway swelling, making breathing difficult. Dexamethasone is a medication that helps to reduce swelling, making breathing easier for children. A standard dose of 0.6mg/kg is used in children. However, a lower amount (due to side effects of steroids in children) has been suggested. We will examine whether 25% less than the standard dose is equally effective in treating croup. Investigators will conduct a clinical study with the support of patients with lived experience (which, in this case, are the parents of the children) to better care for children with croup. If proven, this study can improve the outcome in children with croup.
Detailed description
Croup is a common childhood respiratory disease that leads to frequent emergency department (ED) visits. It accounts for 7% and 3% of hospitalization in under 5 and children between 6 months-3 years in North America, respectively. It is a self-limiting viral infection characterized by the sudden onset of a seal-like barking cough, often accompanied by stridor, voice hoarseness, and respiratory distress. Glucocorticoids are a class of corticosteroids with anti-inflammatory properties that help alleviate croup symptoms. While dexamethasone (a type of glucocorticoid) is commonly used to treat croup at 0.6mg/kg, a low dose of 0.15mg/kg (due to adverse events (AEs)) has been suggested to be equally effective. Investigators propose an innovative and multidisciplinary approach to investigate the noninferiority of dexamethasone at 0.15mg/kg versus 0.6mg/kg to treat croup.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is an internal double-blinded vanguard randomized controlled trial (RCT), which will be conducted at the Winnipeg Children's Hospital (WCH). Computerized randomization will be performed by a statistician at the George and Fay Yee Centre for HealthCare Innovation to generate the randomization list. Investigators will perform a computerized randomization stratified by age. Investigators will do a block randomization with random blocks of undisclosed block sizes over the seasons to ensure temporal distribution of croup cases is captured. Investigators will randomly assign patients to either the intervention or control in ratio 1:1. While croup is common between 6 months and 5 years, a typical croup affects children between 6 months and 3 years. Based on this, we will randomize such that this age category (6 months-3years) has almost similar distribution in each arm.
| Arm | Type | Receives |
|---|---|---|
| 0.15mg/kg dexamethasone | Experimental | Drug: 0.15 mg/kg dexamethasoneTreatment with one dose of oral dexamethasone (0.15 mg/kg per dose; maximum single dose 3 mg) |
| Standard practice of 0.6mg/kg dexamethasone | Active comparator | Drug: 0.15 mg/kg dexamethasoneTreatment with one dose of oral dexamethasone (0.6 mg/kg per dose; maximum single dose 12 mg) |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged with clinical diagnosis of croup
Key exclusion criteria (6 listed)
- Children who are unable to tolerate or ingest oral dexamethasone,
- Known hypersensitivity/allergy to dexamethasone,
- Other causes of stridor (such as acute epiglottitis, bacterial tracheitis, anaphylaxis, foreign body aspiration),
- Other underlying systemic diseases defined as chronic lung disease, chronic heart disease, chronic kidney disease, and immunodeficiency),
- Recent exposure to varicella,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.15 mg/kg dexamethasone25% less than the standard practice of dexamethasone at 0.6mg/kg | Drug | 0.15mg/kg dexamethasone, Standard practice of 0.6mg/kg dexamethasone |
Primary outcome
Return Visits or Readmissions to the Hospital
Time frame: Seven days following initial presentation to the ED with croup.
Return visits or readmissions to the hospital within 7 days following initial presentation to the ED with croup.
1 secondary outcome
Adverse Events
Time frame: within 7 and 30 days of treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42249465Jiang A, Aregbesola A, Gangwani A, Klassen TP, Plint AC, Doyle E, Craig W, Eltorki M, Oketola B, Badran H, Ouyang Y, Heath A. Remote, bivariate prior elicitation for a Bayesian non-inferiority randomized controlled trial. Trials. 2026 Jun 5. doi: 10.1186/s13063-026-09828-8. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Aregbesola, MD, PhD principal investigator
University of Manitoba
Terry Klassen, MD, MSc principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.15 mg/kg dexamethasone in people with Croup, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return Visits or Readmissions to the Hospital (time frame: Seven days following initial presentation to the ED with croup.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06272383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.