Pre School Viral Wheeze
Conditions
Interventions
Trade Name: Prednisolone tablet 25 mg
Product Name: Prednisolone 25 mg tablet
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule*
Sponsors
University Hospital Leicester R&D
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. The primary outcome measure is the Length of stay in hospital ; Secondary Objective: The secondary objectives are: 1. To check whether there is difference in the severity of respiratory distress at 4 and 12 hours 2. To check whether there is difference in the total severity of the attack, or the total amount of inhaled b2-agonists 3. and if there is any difference in the re-admission to hospital within 4 weeks ;Primary end point(s): The primary outcome measure is the Length of stay in hospital | — |
Countries
United Kingdom
Outcome results
None listed