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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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SLCTR |
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Last refreshed on:
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1 April 2024 |
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Main ID: |
SLCTR/2015/003 |
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Date of registration:
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2015-01-21 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Montelukast in Acute Bronchiolitis
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Scientific title:
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Randomized controlled trial on the effectiveness of montelukast in reducing symptoms and hospital stay in children with acute bronchiolitis aged 3 to 18 months |
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Date of first enrolment:
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2015-01-27 |
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Target sample size:
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92 |
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Recruitment status: |
Withdrawn |
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URL:
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https://slctr.lk/trials/slctr-2015-003 |
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Study type:
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Interventional |
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Study design:
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Randomized controlled trial
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Phase:
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Not Applicable
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Countries of recruitment
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Sri Lanka
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Contacts
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Name:
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Dr. Guwani Liyanage
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Address:
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Head of the Department
Department of Paediatrics
Faculty of Medical Sciences
University of Sri Jayawardenepura
Gangodawila, Nugegoda, Sri Lanka.
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Telephone:
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Email:
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guwanil@yahoo.co.uk |
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Affiliation:
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Consultant peadiatrician/ Senior Lecturer |
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Name:
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Dr. Guwani Liyanage
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Address:
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Head of the Department
Department of Paediatrics
Faculty of Medical Sciences
University of Sri Jayawardenepura
Gangodawila, Nugegoda, Sri Lanka.
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Telephone:
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Email:
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guwanil@yahoo.co.uk |
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Affiliation:
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Consultant peadiatrician/ Senior Lecturer |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Children between 3 months and 18 months with clinical features which are considered in making a diagnosis of bronchiolitis such as prodromal fever, rhinorrhoea and cough
2. At least 2 of the following signs on admission: chest retractions, tachypnoea, wheezing
Exclusion criteria: 1. Symptoms lasting for more than 5 days before admission
2. Previous history of wheezing
3. Underlying chronic diseases eg. cardiac disease
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Bronchiolitis
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Intervention(s)
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Participants will be randomized into 2 arms.
Arm 1 (intervention group) will be given 4mg of montelukast sachets/tabs, starting in the evening of the day of admission and continuing each evening for 7 days in addition to standard treatment according to unit protocol.
Arm 2 (control group) will be treated with standard therapy according to the unit protocol without montelukast
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Primary Outcome(s)
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The length of stay in days from admission to discharge. Fitness to discharge will be assessed by Wang clinical severity score, need for nebulization and feeding. [Twice daily until discharge and at the end of 7 days of treatment]
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Secondary Outcome(s)
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Wang clinical severity score evolution
[Twice daily until discharge and at the end of 7 days of treatment]
Oxygen saturation [Twice daily until discharge and at the end of 7 days of treatment]
Pulse rate [Twice daily until discharge and at the end of 7 days of treatment ]
Need for ICU care [Twice daily until discharge and at the end of 7 days of treatment ]
Need for add on therapy [Twice daily until discharge and at the end of 7 days of treatment ]
Readmission rate over the 7 days following discharge [Twice daily until discharge and at the end of 7 days of treatment ]
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Source(s) of Monetary Support
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None
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Ethics review
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Status: Approved
Approval date: 25/09/2014
Contact:
erc.fms.usjp@gmail.com
Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura
+94-112758000 (Extension: 4075)
erc.fms.usjp@gmail.com
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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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