Clinical trial NCT06272383: Croup Dosing Study
Official title: 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Croup
Keywords: Croup, Dexamethasone, Bayesian elicitation, Dosing study, Patient engagement
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Return visits or readmissions to the hospital
timeFrame: Seven days following initial presentation to the ED with croup.
Secondary outcomes:
measure: Adverse events
timeFrame: within 7 and 30 days of treatment.
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Children's Hospital Winnipeg
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Alex Aregbesola, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: Terry Klassen, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: