Home » Trials » SLCTR/2015/003
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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SLCTR Registration Number
SLCTR/2015/003
Date of Registration
The date of last modification
Jul 09, 2019
Scientific Title of Trial
Randomized controlled trial on the effectiveness of montelukast in reducing symptoms and hospital stay in children with acute bronchiolitis aged 3 to 18 months
Public Title of Trial
Montelukast in Acute Bronchiolitis
Disease or Health Condition(s) Studied
Bronchiolitis
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1158-5075
Any other number(s) assigned to the trial and issuing authority
51/14 (University of Sri Jayawardenepura)
What is the research question being addressed?
What is the effectiveness of montelukast in reducing symptoms and hospital stay in patients between 3 months to 18 months with acute bronchiolitis?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
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
Inclusion criteria
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
At least 2 of the following signs on admission: chest retractions, tachypnoea, wheezing
Exclusion criteria
Primary outcome(s)
|
1.
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 ] |
Secondary outcome(s)
|
1.
Wang clinical severity score evolution |
[ Twice daily until discharge and at the end of 7 days of treatment ] |
|
2.
Oxygen saturation |
[ Twice daily until discharge and at the end of 7 days of treatment ] |
|
3.
Pulse rate |
[ Twice daily until discharge and at the end of 7 days of treatment ] |
|
4.
Need for ICU care |
[ Twice daily until discharge and at the end of 7 days of treatment ] |
|
5.
Need for add on therapy |
[ Twice daily until discharge and at the end of 7 days of treatment ] |
|
6.
Readmission rate over the 7 days following discharge |
[ Twice daily until discharge and at the end of 7 days of treatment ] |
Target number/sample size
92
Countries of recruitment
Sri Lanka
Anticipated start date
2015-01-27
Anticipated end date
2015-06-03
Date of first enrollment
Date of study completion
Recruitment status
Withdrawn
Funding source
None
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2014-09-25
Approval number
51/14
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura |
| Institutional Address: | Gangodawila, Nugegoda Sri Lanka |
| Telephone: | +94-112758000 (Extension: 4075) |
| Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Guwani Liyanage
Consultant peadiatrician/ Senior Lecturer
Head of the Department
Department of Paediatrics
Faculty of Medical Sciences
University of Sri Jayawardenepura
Gangodawila, Nugegoda, Sri Lanka.
0773593785
guwanil@yahoo.co.uk
Contact Person for Public Queries
Dr. Guwani Liyanage
Consultant peadiatrician/ Senior Lecturer
Head of the Department
Department of Paediatrics
Faculty of Medical Sciences
University of Sri Jayawardenepura
Gangodawila, Nugegoda, Sri Lanka.
0773593785
guwanil@yahoo.co.uk
Primary study sponsor/organization
Department of Paediatrics
Faculty of Medical Sciences
University of Sri Jayawardenepura
Gangodawila, Nugegoda, Sri Lanka.
Tel: 0112-758654
paedfmsusjp@gmail.com
http://medical.sjp.ac.lk/index.php/about-the-faculty-home/departments/department-of-paediatrics
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
