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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: |
ISRCTN32365107 |
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Date of registration:
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28/07/2004 |
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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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Assessment and management of children aged 1 - 59 months presenting with wheeze and fast breathing: multicenter study in Pakistan and Thailand
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Scientific title:
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Date of first enrolment:
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01/05/2001 |
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Target sample size:
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1622 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN32365107 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Pakistan
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Thailand
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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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Shamim
Qazi |
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Address:
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World Health Organization
20 Avenue Appia
CH 1211
Geneva-27
Switzerland |
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Telephone:
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Email:
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qazis@who.int |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age 1 to 59 months
2. Audible/auscultatory wheeze
3. Respiratory rate above age specific cut off point or lower chest indrawing
4. Classified as no pneumonia with wheeze
Exclusion criteria: 1. Presence of danger sign:
1.1. Up to two months: stopped feeding well, drowsy, convulsions, stridor in a calm child, fever
1.2. 2 - 59 months: convulsions, clinically severe malnutrition, unable to drink
2. Antibiotics during last 48 hours
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Wheeze and fast breathing
Respiratory
Respiratory problems
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Intervention(s)
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1. Inhaled Salbutamol and reassessment after up to three cycles of bronchodilator therapy repeated at 15 minute interval if necessary
2. Metered Dose Inhaler (MDI) with spacer device
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Primary Outcome(s)
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Proportions of children aged 1 - 59 months with auscultatory wheeze and fast breathing or lower chest indrawing:
1. Respond to up to three cycles of inhaled salbutamol: response defined as no fast breathing or lower chest indrawing present
2. Fail therapy at day 3 or days 5 - 7 of the initial successful bronchodilator therapy with inhaled salbutamol? Therapy failure defined as:
2.1. Relapse: develop fast breathing or chest indrawing afresh, that does not respond to three cycles of inhaled salbutamol
2.2. Development of any danger sign (except wheezing and fever in young infant)
2.3. Death
2.4. Severe adverse reaction to salbutamol
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Secondary Outcome(s)
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In children aged 1 - 59 months with auscultatory wheeze and fast breathing or lower chest indrawing:
1. Proportion with audible wheeze at initial assessment
2. Proportion of responders to up to three cycles of inhaled salbutamol associated with:
2.1. Age
2.2. Respiratory Syncytial Virus (RSV) isolation
2.3. Season
2.4. Number of previous wheezing episodes
2.5. Audible versus auscultatory wheeze
2.6. Family history of asthma
3. Proportion of relapses in children who showed initial improvement associated with:
3.1. Age
3.2. RSV isolation
3.3. Season
3.4. Number of previous wheezing episodes
3.5. Audible versus auscultatory wheeze
3.6. Family history of asthma
4. Received any antibiotic for this or any concurrent illness before follow-up
5. Loss to follow-up
6. Withdrawal of consent
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Secondary ID(s)
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WHO/CAH ID 99025
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Source(s) of Monetary Support
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The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
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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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