Croup Dosing Study

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.

Study Overview

• Status: Completed
• Conditions: Croup
• Intervention / Treatment: Drug: 0.15 mg/kg dexamethasone

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Children's Hospital Winnipeg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.15mg/kg dexamethasone; Treatment with one dose of oral dexamethasone (0.15 mg/kg per dose; maximum single dose 3 mg)	Drug: 0.15 mg/kg dexamethasone; 25% less than the standard practice of dexamethasone at 0.6mg/kg
Active Comparator: Standard practice of 0.6mg/kg dexamethasone; Treatment with one dose of oral dexamethasone (0.6 mg/kg per dose; maximum single dose 12 mg)	Drug: 0.15 mg/kg dexamethasone; 25% less than the standard practice of dexamethasone at 0.6mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Seven days following initial presentation to the ED with croup.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within 7 and 30 days of treatment.

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Alex Aregbesola, MD, PhD, University of Manitoba; Principal Investigator: Terry Klassen, MD, MSc, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2024
• Primary Completion (Actual): January 28, 2025
• Study Completion (Actual): February 20, 2025

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Croup, Dexamethasone, Bayesian elicitation, Dosing study, Patient engagement
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Laryngitis; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Croup; Patient Participation; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Dexamethasone
• Other Study ID Numbers: HS26166 (B2023:092)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No