Croup Dosing Study

NCT06272383 | Completed Phase 3 Results DMC

• 1 other identifier: HS26166 (B2023:092)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Croup

Keywords

Croup, Dexamethasone, Bayesian elicitation, Dosing study, Patient engagement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse Events

  within 7 and 30 days of treatment.

Study Arms (2)

0.15mg/kg dexamethasone

EXPERIMENTAL

Treatment with one dose of oral dexamethasone (0.15 mg/kg per dose; maximum single dose 3 mg)

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)

Drug: 0.15 mg/kg dexamethasone

Interventions

0.15 mg/kg dexamethasone DRUG

25% less than the standard practice of dexamethasone at 0.6mg/kg

0.15mg/kg dexamethasone; Standard practice of 0.6mg/kg dexamethasone

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged with clinical diagnosis of croup

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Children's Hospital Winnipeg

Winnipeg, Manitoba, Canada

Location

MeSH Terms

Conditions

Croup; Patient Participation

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Laryngitis; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr Alex Aregbesola
• Organization: University of Manitoba

Alex.Aregbesola@umanitoba.ca

2047893957

Study Officials

• Alex Aregbesola, MD, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Terry Klassen, MD, MSc

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: June 5, 2024
• Primary Completion: January 28, 2025
• Study Completion: February 20, 2025
• Last Updated: September 8, 2025
• Results First Posted: September 8, 2025

Record last verified: 2025-07

Locations

CA (1)