Use of Montelukast in acute moderate bronchiolitis.(3 months to 2 years)

Not yet recruiting

• Conditions: Acute bronchiolitis, unspecified,

• Registration Number: CTRI/2019/07/020456
• Lead Sponsor: Megadeepan S

Brief Summary

Study title:

Role of Montelukast in children (aged 3 months to                         2 years)  hospitalised with acute moderate bronchiolitis



Research question:



Is Montelukast effective for acute bronchiolitis?



Aim:



To assess the efficacy of Montelukast in children (aged 3 months to 2 years) with acute moderate bronchiolitis.



OBJECTIVES:



Primary objective:

To assess and compare the change in length of hospital stay between groups of children receiving Montelukast and not receiving Montelukast in children hospitalised with acute moderate bronchiolitis.



Secondary objectives:



1) To assess the change in clinical severity score (WANG  score) between groups of children receiving Montelukast and not receiving Montelukast in children hospitalised with acute moderate bronchiolitis.



2) To assess and compare the oxygen requirement (hours) between groups of children receiving Montelukast and not receiving Montelukast in children hospitalised with acute moderate bronchiolitis.



3) To assess and compare intravenous fluid requirement (hours) between groups of children receiving Montelukast and not receiving Montelukast in children hospitalised with acute moderate bronchiolitis.



4) To assess the incidence of adverse events following Montelukast administration.



Setting:



This study will be conducted in Paediatric Department of Swami Dayanand hospital, Delhi.



Study design:



This study will be a randomized double blinded placebo controlled clinical trial.



Study Duration:



February 2019 to November 2020 (22 months)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-08
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 1. Children aged 3 months to 2 years with first episode of wheezing having a prodromal history consistent with upper respiratory tract infection followed by wheezing and/or crackles on auscultation.
• 2. WANG score 4 to 8.

Exclusion Criteria

• 1. Age greater than 2 years and age less than 3 months.
• 2. Baby born premature (less than 34 weeks).
• 3. Previous hospital admission due to any respiratory illness.
• 4. Previous bronchodilator use before the present illness.
• 5. Previous steroid use before the present illness.
• 6. Chronic cardiac or pulmonary disease.
• 7. History of atopy in child or family.
• 8. Oxygen saturation ≤ 85% in room air at the time of recruitment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess and compare the change in length of hospital stay between groups of children receiving Montelukast and not receiving Montelukast in children hospitalised with acute moderate bronchiolitis.	From the time of admission to time of discharge.

Secondary Outcome Measures

Name	Time	Method
1) Change in clinical severity score (WANG score).	2) Oxygen requirement.

Trial Locations

Locations (1)

Swami Dayanand hospital; 🇮🇳 East, DELHI, India

Swami Dayanand hospital

🇮🇳East, DELHI, India

MegadeepanS

Principal investigator

9659377834

megaaa567@gmail.com