A comparison of oral prednisolone and oral dexamethasone in children with croup: a prospective, randomised, double blinded multicentre trial
Phase 4
Completed
- Conditions
- Croup (laryngotracheitis, laryngotracheobronchitis)Respiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12609000290291
- Lead Sponsor
- Dr Colin Parker
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1400
Inclusion Criteria
Clinical diagnosis of croup
Age 6 months to 10 years
Weight no more than 20 kg
Parents contactable by telephone
Parents speak English
Exclusion Criteria
High clinical suspicion of an alternative diagnosis,
Known allergy to prednisolone or dexamethasone,
Immunosuppressive disease or treatment,
Steroid therapy in past 14 days,
Enrolment in this study in past 14 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Westley Croup Score (a validated measure of croup severity, based on clinical observations of stridor, retractions, air entry, cyanosis, and level of consciousness)[0, 1, 2, 3, 4, 5, 6, 12 hours after the treatment is administered];Unscheduled medical re-attendance rate, as assessed by follow-up telephone call[During the 7 days post-treatment]
- Secondary Outcome Measures
Name Time Method