Croup Dosing Study

Phase 3

Completed

• Conditions: Croup
• Interventions: Drug: 0.15 mg/kg dexamethasone

• Registration Number: NCT06272383
• Lead Sponsor: University of Manitoba

Brief 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.

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 Timeline

• Study First Submitted: 2024-02-15
• Study First Submitted QC: 2024-02-15
• Study First Posted: 2024-02-22
• Study Start: 2024-06-05
• Primary Completion: 2025-01-28
• Study Completion: 2025-02-20
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.15mg/kg dexamethasone	0.15 mg/kg dexamethasone	Treatment with one dose of oral dexamethasone (0.15 mg/kg per dose; maximum single dose 3 mg)
Standard practice of 0.6mg/kg dexamethasone	0.15 mg/kg dexamethasone	Treatment with one dose of oral dexamethasone (0.6 mg/kg per dose; maximum single dose 12 mg)

Primary Outcome Measures

Name	Time	Method
Return visits or readmissions to the hospital	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.

Secondary Outcome Measures

Name	Time	Method
Adverse events	within 7 and 30 days of treatment.	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.

Trial Locations

Locations (1)

Children's Hospital Winnipeg; 🇨🇦 Winnipeg, Manitoba, Canada