Dexamethasone for Croup

Overseen By Banke Oketola, MSc

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Manitoba

Must not be taking: Corticosteroids

Disqualifiers: Hypersensitivity to dexamethasone, Stridor causes, Chronic diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 1 day

50 Participants Needed

Trial Summary

What is the purpose of this 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.

Research Team

Alex Aregbesola, MD, PhD

Principal Investigator

University of Manitoba

Terry Klassen, MD, MSc

Principal Investigator

University of Manitoba

Eligibility Criteria

This trial is for children who have been clinically diagnosed with croup, a respiratory condition causing cough and difficulty breathing. The study aims to find out if a lower dose of dexamethasone is effective in treating croup symptoms.

Inclusion Criteria

My child has been diagnosed with croup.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of oral dexamethasone at either 0.15 mg/kg or 0.6 mg/kg

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and return visits to the hospital

4 weeks

Follow-up within 7 and 30 days post-treatment

Treatment Details

Interventions

• Dexamethasone

Trial Overview The study tests whether 0.15 mg/kg of dexamethasone, which is 25% less than the standard dose, can effectively treat croup in children without compromising results. It's designed to potentially improve treatment by reducing steroid-related side effects.

Participant Groups

Group I: 0.15mg/kg dexamethasone Experimental Treatment 1 Intervention

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

Group II: Standard practice of 0.6mg/kg dexamethasone Active Control 1 Intervention

Treatment with one dose of oral dexamethasone (0.6 mg/kg per dose; maximum single dose 12 mg)

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+