Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272383
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-02-15
Brief Title:
Croup Dosing Study
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Using a Single Dose of Dexamethasone at 06mgkg of Body Weight Versus 015 mgkg of Body Weight for the Treatment of Croup an Internal Vanguard Randomized Controlled Non-Inferiority Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 06mgkg 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 06mgkg a low dose of 015mgkg 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 015mgkg versus 06mgkg to treat croup
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None