Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.15mg/kg dexamethasone | Experimental | Treatment with one dose of oral dexamethasone (0.15 mg/kg per dose; maximum single dose 3 mg) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.15 mg/kg dexamethasone | Drug | 25% less than the standard practice of dexamethasone at 0.6mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 7 and 30 days of treatment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alex Aregbesola, MD, PhD | University of Manitoba | Principal Investigator |
| Terry Klassen, MD, MSc | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Winnipeg | Winnipeg | Manitoba | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42249465 | Derived | Jiang A, Aregbesola A, Gangwani A, Klassen TP, Plint AC, Doyle E, Craig W, Eltorki M, Oketola B, Badran H, Ouyang Y, Heath A. Remote, bivariate prior elicitation for a Bayesian non-inferiority randomized controlled trial. Trials. 2026 Jun 5. doi: 10.1186/s13063-026-09828-8. Online ahead of print. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 0.15mg/kg Dexamethasone | Treatment with one dose of oral dexamethasone (0.15 mg/kg per dose; maximum single dose 3 mg) 0.15 mg/kg dexamethasone: 25% less than the standard practice of dexamethasone at 0.6mg/kg |
| FG001 | Standard Practice of 0.6mg/kg Dexamethasone | Treatment with one dose of oral dexamethasone (0.6 mg/kg per dose; maximum single dose 12 mg) 0.15 mg/kg dexamethasone: 25% less than the standard practice of dexamethasone at 0.6mg/kg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 0.15mg/kg Dexamethasone | Treatment with one dose of oral dexamethasone (0.15 mg/kg per dose; maximum single dose 3 mg) 0.15 mg/kg dexamethasone: 25% less than the standard practice of dexamethasone at 0.6mg/kg |
| BG001 | Standard Practice of 0.6mg/kg Dexamethasone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | Seven days following initial presentation to the ED with croup. |
|
over 7 days and 30 days
Patient severely ill were excluded from the study
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.15mg/kg Dexamethasone | Treatment with one dose of oral dexamethasone (0.15 mg/kg per dose; maximum single dose 3 mg) 0.15 mg/kg dexamethasone: 25% less than the standard practice of dexamethasone at 0.6mg/kg |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Alex Aregbesola | University of Manitoba | 2047893957 | Alex.Aregbesola@umanitoba.ca |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2024 | Aug 12, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003440 | Croup |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D007827 | Laryngitis |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Treatment with one dose of oral dexamethasone (0.6 mg/kg per dose; maximum single dose 12 mg) 0.15 mg/kg dexamethasone: 25% less than the standard practice of dexamethasone at 0.6mg/kg |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| weight (Kg) | Mean | Full Range | Kg |
|
| croup severity | Croup severity by Westley croup scores - mild moderate severe | Number | participants |
|
|
|
| Secondary | 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. | Posted | Number | participants | within 7 and 30 days of treatment. |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Standard Practice of 0.6mg/kg Dexamethasone | Treatment with one dose of oral dexamethasone (0.6 mg/kg per dose; maximum single dose 12 mg) 0.15 mg/kg dexamethasone: 25% less than the standard practice of dexamethasone at 0.6mg/kg | 0 | 21 | 0 | 21 | 0 | 21 |
Not provided
Not provided
Not provided
| D010342 |
| Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |