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
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Treatment with one dose of oral dexamethasone (0.15 mg/kg per dose; maximum single dose 3 mg)
Treatment with one dose of oral dexamethasone (0.6 mg/kg per dose; maximum single dose 12 mg)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Manitoba
Lead Sponsor
Citations
An Overview of the Effectiveness of Corticoids in Croup
The study showed that 0.15 mg/kg of oral dexamethasone effectively lowered the overall croup score, although it did not statistically affect ...
A Randomized Trial of a Single Dose of Oral ...
In the dexamethasone group, there was quicker resolution of croup symptoms (P=0.003), less lost sleep (P<0.001), and less stress on the part of the parent (P< ...
3.
shmpublications.onlinelibrary.wiley.com
shmpublications.onlinelibrary.wiley.com/doi/10.1002/jhm.13542?af=RDexamethasone regime and clinical outcomes in children ...
Of 471 children hospitalized for croup, 229 (49%) received 1 dose of dexamethasone; 242 (51%) received >1 dose. In the propensity-weighted ...
27 years of croup: an update highlighting the effectiveness ...
Results: The dramatic improvements in outcomes for croup, including reduced admission rates, length of stay, transfers to the intensive care unit, intensive ...
5.
publications.aap.org
publications.aap.org/pediatrics/article/144/3/e20183772/76989/Prednisolone-Versus-Dexamethasone-for-Croup-aPrednisolone Versus Dexamethasone for Croup
27 years of croup: an update highlighting the effectiveness of 0.15 mg/kg of dexamethasone ... outcomes measured (croup score and re-attendance).
The Outcome of Immediate Administration ...
We found an Australian study that showed that an oral dose of 0.15 mg/kg dexamethasone offered benefit to children with croup as early as 30 ...
Dexamethasone regime and clinical outcomes in children ...
Of 471 children hospitalized for croup, 229 (49%) received 1 dose of dexamethasone; 242 (51%) received >1 dose. In the propensity‐weighted analyses, children ...
8.
shmpublications.onlinelibrary.wiley.com
shmpublications.onlinelibrary.wiley.com/doi/pdf/10.1002/jhm.13542Dexamethasone regime and clinical outcomes in children ...
Results: Of 471 children hospitalized for croup, 229 (49%) received 1 dose of dexamethasone; 242 (51%) received >1 dose. In the propensity‐ ...
Croup: Diagnosis and Management
Treatment with dexamethasone results in faster resolution of symptoms and decreased return to medical care. Corticosteroids are thought to work ...
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