Phase 3
N=50
Croup Dosing Study
Croup
Bottom Line
View on ClinicalTrials.gov: NCT06272383 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Return Visits or Readmissions to the Hospital — 0; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 0.15 mg/kg dexamethasone (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Manitoba
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Return Visits or Readmissions to the Hospital |
0; 2 | — |
| SECONDARY Adverse Events |
0; 0 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- Children aged with clinical diagnosis of croup
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT06272383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.