Croup
Conditions
Keywords
Croup, Dexamethasone, Bayesian elicitation, Dosing study, Patient engagement
Brief summary
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.
Detailed description
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.
Interventions
DRUG0.15 mg/kg dexamethasone
25% less than the standard practice of dexamethasone at 0.6mg/kg
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* Children aged with clinical diagnosis of croup
Exclusion criteria
* Children who are unable to tolerate or ingest oral dexamethasone, * Known hypersensitivity/allergy to dexamethasone, * Other causes of stridor (such as acute epiglottitis, bacterial tracheitis, anaphylaxis, foreign body aspiration), * Other underlying systemic diseases defined as chronic lung disease, chronic heart disease, chronic kidney disease, and immunodeficiency), * Recent exposure to varicella, * Treatment with oral or intravenous corticosteroids within the preceding 72 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Return Visits or Readmissions to the Hospital | Seven days following initial presentation to the ED with croup. | Return visits or readmissions to the hospital within 7 days following initial presentation to the ED with croup. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | within 7 and 30 days of treatment. | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 19 |
| 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 | 21 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | The investigational drugs were going to expire and to use the pilot data for the definitive trial | 6 | 4 |
Baseline characteristics
| Characteristic | 0.15mg/kg Dexamethasone | Standard Practice of 0.6mg/kg Dexamethasone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 19 Participants | 21 Participants | 40 Participants |
| Age, Categorical >=65 years | NA Participants | NA Participants | NA Participants |
| Age, Categorical Between 18 and 65 years | NA Participants | NA Participants | NA Participants |
| croup severity Mild croup | 16 participants | 16 participants | 32 participants |
| croup severity Moderate croup | 3 participants | 4 participants | 7 participants |
| croup severity Severe croup | 0 participants | 1 participants | 1 participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 16 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 24 Participants |
| weight (Kg) | 13.17 Kg | 13.69 Kg | 13.45 Kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 21 |
| other Total, other adverse events | 0 / 19 | 0 / 21 |
| serious Total, serious adverse events | 0 / 19 | 0 / 21 |
Outcome results
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.
Time frame: Seven days following initial presentation to the ED with croup.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 0.15mg/kg Dexamethasone | Return Visits or Readmissions to the Hospital | 0 participants |
| Standard Practice of 0.6mg/kg Dexamethasone | Return Visits or Readmissions to the Hospital | 2 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.
Time frame: within 7 and 30 days of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 0.15mg/kg Dexamethasone | Adverse Events | 0 participants |
| Standard Practice of 0.6mg/kg Dexamethasone | Adverse Events | 0 participants |