Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing
- Registration Number
- NCT01370187
- Lead Sponsor
- Hormozgan University of Medical Sciences
- Brief Summary
The aim of the current study is to evaluate the effect of Montelukast in treatment of acute bronchiolitis and postbronchiolitis viral induced wheezing of infants 3 to 12 months of age in Bandar Abbas Children' hospital.
- Detailed Description
All the patients will be evaluated at the baseline, during hospitalization (daily) and at 2 months and 6 months after starting the intervention.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 146
Inclusion Criteria
- infant in 3-12 months of age with first episode of wheezing or bronchiolitis
- written informed consent by parents
Exclusion Criteria
- Previous wheezing episode or confirmed asthma or bronchiolitis
- recent bronchodilator use
- immune deficient
- immunosuppressive drug use
- croup or pneumonia diagnosis
- loss of follow up
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Montelukast Montelukast 4mg Montelukast daily for 2 months
- Primary Outcome Measures
Name Time Method Respiratory Distress Severity Score (RDSS) participants will be followed for the duration of hospital stay, an expected average of 3 days RDSS is measured by wheezing (0, 1, 2)+ Cough (0, 1, 2)+Retraction (0, 1,2)+Respiratory rate(0,1,2)+ Oxygen saturation(0,1,2) scores
- Secondary Outcome Measures
Name Time Method average number of cough daily= as expressed parents during visits 6 months none= No cough, Mild=less than 10 daily, Severe=More than 10 daily
Wheezing severity in the physical examination by physician 6 Months None= no wheezing, Mild= mild expiratory, Severe= inspiratory and expiratory
Trial Locations
- Locations (1)
Hormozgan University of Medical Sciences (HUMS)
🇮🇷Bandar Abbas, Hormozgan, Iran, Islamic Republic of