Croup Dosing Study

University of Manitoba

Status and phase

Completed

Phase 3

Conditions

Croup

Treatments

Drug: 0.15 mg/kg dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT06272383

HS26166 (B2023:092)

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

6 months to 5 years old

Volunteers

Accepts Healthy Volunteers

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.