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| [ Print-friendly version ] |
| Efficacy of a short course of oral steroids for hospitalised preschool children with viral induced wheeze: a randomised double-blind placebo-controlled trial |
| ISRCTN | ISRCTN58363576 |
| ClinicalTrials.gov identifier | |
| Public title | Efficacy of a short course of oral steroids for hospitalised preschool children with viral induced wheeze: a randomised double-blind placebo-controlled trial |
| Scientific title | |
| Acronym | TWICS (Treatment of Wheeze In Children with Steroids) |
| Serial number at source | Asthma UK Funded Project ID 04/039; EudraCT Number: 2004-005124-40 |
| Study hypothesis |
The outcome for preschool children (10 months to 60 months) admitted to the hospital with an attack of wheeze triggered by clinical viral infection (preschool viral wheeze) and treated with oral steroids will be no different than those children treated with placebo (primary null hypothesis).
Secondary (null) hypotheses are that compared with oral placebo, treatment of hospitalised children with preschool viral wheeze with oral prednisolone will not: 1. Reduce the severity of respiratory distress at 4, 12, and 24 hours 2. Reduce the total severity of the attack, or the total amount of inhaled bronchodilators 3. Reduce the risk of significant hypoxia or re-admission within 4 weeks |
| Ethics approval |
1. Fife and Forth Valley Local Research Ethics Committee (MREC ref: 05/S0501/7)
2. Leicestershire Local Research Ethics Committee Two (LREC ref: 05/Q2502/19) 3. Medicines and Healthcare products Regulatory Agency (MHRA) (CTA Number 23071/0001/001-0001) |
| Study design |
Two-centre, three-hospital, randomised, double-blind placebo-controlled trial.
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| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Preschool wheeze: In children between 1 and 5 years the phenotype of 'asthma' is characterised by transient episodes of wheeze triggered by viral colds with no or few interval symptoms |
| Participants - inclusion criteria |
1. Children aged 10 months to 60 months
2. Preceding history of a viral illness with upper respiratory tract symptoms/signs associated with an acute episode of physician diagnosed wheeze (preschool viral wheeze) 3. Who need admission to the hospital |
| Participants - exclusion criteria |
1. Children < 10 months and > 60 months age
2. Fluid resuscitation (more than or equal to 20 ml/kg) 3. Bacterial sepsis (e.g. bacterial pneumonia, meningitis) 4. Cystic fibrosis, bronchiectasis and children with upper respiratory tract structural abnormality 5. Children on home oxygen 6. Diagnosis of immune deficiency 7. History of chronic persistent wheeze with no evidence of a discrete deterioration in association with a clinical cold 8. Active chicken pox 9. Children admitted for social reasons |
| Anticipated start date | 01/01/2005 |
| Anticipated end date | 01/01/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 700 |
| Interventions | By double-blind, stratified (by centre) randomisation, children will receive either oral corticosteroids for 5 days or placebo along with inhaled bronchodilator therapy (frequency and mode of delivery device decided by the clinician). The dose of the oral corticosteroid, prednisolone will be 20 mg for 2 to 5 year olds and 10 mg for children under age of 2 years. |
| Primary outcome measure(s) | Length of stay in hospital, i.e. time from randomisation to discharge from the hospital which will be assessed in two ways: first when the child was felt fit to be discharged by a clinician and second when child was discharged home. |
| Secondary outcome measure(s) |
1. Median symptom score (Preschool Respiratory Assessment Measure [PRAM] score) and parental symptom score (mean 7 day)
2. Total use of inhaled bronchodilators during hospitalisation (from notes) and total for 7 days post discharge (from parental diary and clinical notes) 3. Complications: 3.1. Hypoxia 3.2. Pediatric Intensive Care Unit (PICU) admission 3.3. Readmission within 1 month and withdrawal from the study |
| Sources of funding | Asthma UK (Project ID 04/039) |
| Trial website | |
| Publications | |
| Contact name | Prof Jonathan Grigg |
| Address |
Institute of Cell and Molecular Science
Queen Mary University London Academic Unit of Paediatrics 4 Newark Street |
| City/town | London |
| Zip/Postcode | E1 2AT |
| Country | United Kingdom |
| Tel | +44 (0)20 7882 2206 |
| j.grigg@qmul.ac.uk | |
| Sponsor | Asthma UK |
| Address |
Providence House
Providence Place |
| City/town | London |
| Zip/Postcode | N1 0NT |
| Country | United Kingdom |
| Tel | +44 (0)20 7226 2260 |
| Fax | +44 (0)20 7704 0740 |
| pmajor@asthma.org.uk | |
| Sponsor website: | http://asthma.org.uk/ |
| Date applied | 20/06/2007 |
| Last edited | 21/09/2007 |
| Date ISRCTN assigned | 06/07/2007 |
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