Children's Hospital Winnipeg
Winnipeg, Manitoba, Canada
NCT Number: NCT06272383
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.
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Notify Me6 month–5 year
All sexes
Interventional
Phase 3
Winnipeg, Manitoba, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
25% less than the standard practice of dexamethasone at 0.6mg/kg
Time frame: 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.
Time frame: 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.
University of Manitoba
Other
Using a Single Dose of Dexamethasone at 0.6mg/kg of Body Weight Versus 0.15 mg/kg of Body Weight for the Treatment of Croup: an Internal Vanguard Randomized Controlled Non-Inferiority Trial.
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