A Phase 3 interventional study of 0.15 mg/kg dexamethasone in Croup, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged 6 Months to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by University of Manitoba · Phase 3, Interventional, and Treatment
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.
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.
18 studies on the registry are indexed under Croup; 2 are open to participants now.
This study's enrollment of 50 is below the median of 86 across 12 interventional studies indexed under Croup.
Browse Croup studies →University of Manitoba is the lead sponsor of 555 studies on the registry; 89 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment with one dose of oral dexamethasone (0.15 mg/kg per dose; maximum single dose 3 mg)
Drug: 0.15 mg/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
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.
Time frame: Seven days following initial presentation to the ED with croup.
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.
Time frame: within 7 and 30 days of treatment.
| Milestone | 0.15mg/kg Dexamethasone | Standard Practice of 0.6mg/kg Dexamethasone |
|---|---|---|
| Started | 25 | 25 |
| Completed | 19 | 21 |
| Not completed | 6 | 4 |
| Withdrew: The investigational drugs were going to expire and to use the pilot data for the definitive trial | 6 | 4 |
Return visits or readmissions to the hospital within 7 days following initial presentation to the ED with croup.
| participants | 0.15mg/kg Dexamethasone | Standard Practice of 0.6mg/kg Dexamethasone |
|---|---|---|
| Return Visits or Readmissions to the Hospital | 0 | 2 |
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.
| participants | 0.15mg/kg Dexamethasone | Standard Practice of 0.6mg/kg Dexamethasone |
|---|---|---|
| Adverse Events | 0 | 0 |
Collected over over 7 days and 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 0.15mg/kg Dexamethasone | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Standard Practice of 0.6mg/kg Dexamethasone | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Age, Categorical(Participants) | 0.15mg/kg Dexamethasone | Standard Practice of 0.6mg/kg Dexamethasone | Total |
|---|---|---|---|
| <=18 years | 19 | 21 | 40 |
| Between 18 and 65 years | NA | NA | NA |
| >=65 years | NA | NA | NA |
| Sex: Female, Male(Participants) | 0.15mg/kg Dexamethasone | Standard Practice of 0.6mg/kg Dexamethasone | Total |
|---|---|---|---|
| Female | 7 | 9 | 16 |
| Male | 12 | 12 | 24 |
| Race and Ethnicity Not Collected(Participants) | 0.15mg/kg Dexamethasone | Standard Practice of 0.6mg/kg Dexamethasone | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| weight (Kg)(Kg) | 0.15mg/kg Dexamethasone | Standard Practice of 0.6mg/kg Dexamethasone | Total |
|---|---|---|---|
| Mean | 13.17 (7.50 to 18.10) | 13.69 (8.50 to 20.00) | 13.45 (7.50 to 20.00) |
| croup severity(participants) | 0.15mg/kg Dexamethasone | Standard Practice of 0.6mg/kg Dexamethasone | Total |
|---|---|---|---|
| Mild croup | 16 | 16 | 32 |
| Moderate croup | 3 | 4 | 7 |
| Severe croup | 0 | 1 | 1 |
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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