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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN58363576 |
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Date of registration:
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06/07/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of a short course of oral steroids for hospitalised preschool children with viral induced wheeze: a randomised double-blind placebo-controlled trial
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Scientific title:
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Date of first enrolment:
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01/01/2005 |
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Target sample size:
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700 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN58363576 |
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Study type:
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Interventional |
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Study design:
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Two-centre, three-hospital, randomised, double-blind placebo-controlled trial.
(Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Jonathan
Grigg |
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Address:
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Institute of Cell and Molecular Science
Queen Mary University London
Academic Unit of Paediatrics
4 Newark Street
E1 2AT
London
United Kingdom |
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Telephone:
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+44 (0)20 7882 2206 |
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Email:
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j.grigg@qmul.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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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
Signs and Symptoms
Wheeze
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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
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Secondary ID(s)
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2004-005124-40
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Asthma UK Funded Project ID 04/039; EudraCT Number: 2004-005124-40
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Source(s) of Monetary Support
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Asthma UK (Project ID 04/039)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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