Dexamethasone for Croup
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of a lower dose of dexamethasone, a corticosteroid medication, for treating croup in children. Croup is a viral infection that causes airway swelling, making it difficult for children to breathe. The study will compare a smaller dose of the medication to the standard dose to determine if it is equally effective with fewer side effects. Children diagnosed with croup who can take oral dexamethasone may be suitable candidates for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially safer treatment option for croup.
Will I have to stop taking my current medications?
If your child has been treated with oral or intravenous corticosteroids in the last 72 hours, they cannot participate in the trial. The protocol does not specify about other medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that dexamethasone is generally safe for children with croup. One study found that a small oral dose of 0.15 mg/kg helped children feel better as quickly as 30 minutes after administration. Another study demonstrated that children who took dexamethasone experienced faster relief from symptoms, reducing stress for their parents. This indicates the medicine is well-tolerated.
Dexamethasone is already used as a standard treatment for croup at higher doses, supporting its safety. The current trial tests a lower dose, which may lead to fewer side effects. Overall, the evidence supports dexamethasone as a safe option for managing croup in children.12345Why do researchers think this study treatment might be promising for croup?
Researchers are excited about the use of a lower dose of dexamethasone for treating croup because it aims to offer the same relief with potentially fewer side effects. While the standard treatment involves a single dose of 0.6 mg/kg, this study explores the effectiveness of a smaller 0.15 mg/kg dose. The smaller dose could mean less exposure to the medication's effects while still effectively managing symptoms, making it particularly beneficial for children who are more susceptible to side effects. If successful, this approach could streamline treatment by maintaining efficacy with a gentler impact on the body.
What evidence suggests that this trial's treatments could be effective for croup?
Research has shown that dexamethasone effectively treats croup symptoms in children. In this trial, participants will receive either a small dose of 0.15 mg per kilogram of body weight or the standard dose of 0.6 mg per kilogram. Studies have found that even the smaller dose can reduce symptom severity. One study found that children who took dexamethasone felt better faster, and their parents reported less stress and improved sleep. Dexamethasone, used for many years, reduces hospital visits and the need for intensive care, making it a reliable choice for treating croup in children.36789
Who Is on the Research Team?
Terry Klassen, MD, MSc
Principal Investigator
University of Manitoba
Alex Aregbesola, MD, PhD
Principal Investigator
University of Manitoba
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of oral dexamethasone at either 0.15 mg/kg or 0.6 mg/kg
Follow-up
Participants are monitored for adverse events and return visits to the hospital
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Manitoba
Lead Sponsor