Efficacy of a short course of oral steroids for hospitalised preschool children with viral-induced wheeze; a randomised double-blind placebo-controlled trial
Phase 1
- Conditions
- Pre School Viral Wheeze
- Registration Number
- EUCTR2004-005124-40-GB
- Lead Sponsor
- niversity Hospital Leicester R&D
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 700
Inclusion Criteria
1. Children aged 10 months to 60 months (5 years 0 months).
2. Preceding history of a viral illness with upper respiratory tract symptoms/signs associated with an acute episode of physician diagnosed wheeze (Pre school viral wheeze).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1. Shock requiring fluid resuscitation (more than 10ml/kg)
2. Signs of disseminated disease such as meningism.
3. Cystic fibrosis
4. Clinical signs suggestive of bronchiolitis.
5. Diagnosis of immune deficiency.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: To check whether the outcome for preschool children (10 months to 5 years), admitted to the hospital with an attack of wheeze triggered by clinical viral infection (preschool viral wheeze; PVW), and treated with oral steroids be different from that for those children treated with placebo.<br> The primary outcome measure is the Length of stay in hospital<br> ;<br> Secondary Objective: The secondary objectives are:<br> 1. To check whether there is difference in the severity of respiratory distress at 4 and 12 hours<br> 2. To check whether there is difference in the total severity of the attack, or the total amount of inhaled b2-agonists<br> 3. and if there is any difference in the re-admission to hospital within 4 weeks<br> ;Primary end point(s): The primary outcome measure is the Length of stay in hospital
- Secondary Outcome Measures
Name Time Method