Acute Bronchiolitis
Conditions
Brief summary
This study aims to evaluate the role of Montelukast in management of acute Bronchiolitis in indoor patient and how this drug shortens the duration of admission and improves symptoms
Interventions
DRUGMontelukast
Administrating montelukast to experimental group and monitoring response
DRUGPlacebo
Placebo sugar granules administered orally once daily at night according to the same schedule as montelukast 4 mg sachet, in addition to standard supportive care for acute bronchiolitis
Sponsors
Pakistan Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
4 Weeks to 2 Years
Healthy volunteers
No
Inclusion criteria
* Age 4 weeks to 2 years * Both genders * Duration of respiratory symptoms less than 4 days * Clinical diagnosis of acute bronchiolitis according to the operational definition provided in the study protocol
Exclusion criteria
* History of asthma * Previous hospital admissions for respiratory illness * Use of asthma medications * Congenital heart disease * Bronchopulmonary dysplasia * Immunodeficiency * Immunosuppression * Radiological evidence of pneumonia, including infiltrates or patches on chest X-ray
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Severity Score from Baseline to 72 Hours | Baseline (hospital admission) and 72 hours after initiation of treatment | Change in the study-defined Clinical Severity Score from baseline at hospital admission to 72 hours after initiation of treatment. The score ranges from 0 to 12 and is calculated from heart rate, wheezing, respiratory rate, dyspnea, respiratory support, and feeding difficulties, with each component scored from 0 to 2. Higher scores indicate greater clinical severity. The change in score will be compared between the montelukast and placebo groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | From baseline (hospital admission;day 1) through hospital discharge ( day 7) | Length of hospital stay measured in hours from hospital admission until hospital discharge. Discharge is defined by resolution of symptoms, including improved feeding, absence of respiratory distress, a clinical severity score less than 3, and respiratory rate within the normal range for age. |
Countries
Pakistan
Contacts
CONTACTDr Haniyah Anwar, M.B.B.S
PRINCIPAL_INVESTIGATORDr Haniyah Anwar
Pakistan Institute of Medical Sciences
Outcome results
None listed