| CTRI Number |
CTRI/2019/07/020456 [Registered on: 31/07/2019] Trial Registered Prospectively |
| Last Modified On: |
30/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of Montelukast in acute moderate bronchiolitis.(3 months to 2 years) |
|
Scientific Title of Study
|
Role of Montelukast in children (aged 3 months to 2 years) hospitalized with acute moderate bronchiolitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Megadeepan |
| Designation |
Trainee in DNB paediatrics |
| Affiliation |
Swami Dayanand hospital |
| Address |
Dr.Megadeepan.S,Trainee in DNB Paediatrics in department of paediatrics, OPD block room no.316,OPD block, 3rd floor, Swami dayanand hospital, Dilshad Garden, Delhi.
East
DELHI
110095
India |
| Phone |
9659377834 |
| Fax |
|
| Email |
megaaa567@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand Agarwal |
| Designation |
M.D. Paediatrics, Head of Department, Paediatrics, SDN Hospital, Delhi. |
| Affiliation |
Swami Dayanand hospital |
| Address |
Room no.315,OPD block, 3rd floor, Swami dayanand hospital, Dilshad Garden, Delhi.
East
DELHI
110095
India |
| Phone |
9810902271 |
| Fax |
|
| Email |
anand1hari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Megadeepan |
| Designation |
Trainee in DNB paediatrics |
| Affiliation |
Swami Dayanand hospital |
| Address |
Dr.Megadeepan.S,Trainee in DNB Paediatrics in department of paediatrics, OPD block room no.316,OPD block, 3rd floor, Swami dayanand hospital, Dilshad Garden, Delhi.
East
DELHI
110095
India |
| Phone |
9659377834 |
| Fax |
|
| Email |
megaaa567@gmail.com |
|
|
Source of Monetary or Material Support
|
| Megadeepan S, Room no.18, 2nd floor, DNB residents hostel, Swami Dayanand hospital,Delhi -110095. |
|
|
Primary Sponsor
|
| Name |
Megadeepan S |
| Address |
Room no.18, 2nd floor, DNB residents hostel, Swami Dayanand hospital, Dilshad Garden, Delhi-110095. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| MegadeepanS |
Swami Dayanand hospital |
Ward 4 & 5, Department of Paediatrics, Children ward, 1st floor, Emergency building, Swami Dayanand hospital, Dilshad Garden, Delhi-110095.
East
DELHI |
9659377834
megaaa567@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J219||Acute bronchiolitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Children receiving Montelukast |
We will give Montelukast (dispersible tablet) 4mg (once daily) orally to children (aged 3 months to 2 years) hospitalised with acute moderate bronchiolitis. Assess the duration of length of hospital stay between the groups of children receiving Montelukast and in those children not receiving Montelukast. |
| Comparator Agent |
Placebo |
We will give placebo 4mg (once daily) orally to children (aged 3 months to 2 years) hospitalised with acute moderate bronchiolitis. Placebo will be similar to Montelukast in all aspects. 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. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
1) Change in clinical severity score (WANG score).
2) Oxygen requirement.
3) Intravenous fluid requirement.
4) Incidence of adverse effects following Montelukast administration. |
From the time of admission to time of discharge. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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) |