| CTRI Number |
CTRI/2024/03/063668 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Dexamethasone in children of age group 1 month to 2 years suffering from acute bronchiolitis |
|
Scientific Title of Study
|
Dexamethasone in Acute Bronchiolitis A Randomized controlled trial DEXTER trial |
| Trial Acronym |
DEXTER Trail |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR CHONGTHAM VIJAYLAXMI DEVI |
| Designation |
PG JUNIOR RESIDENT |
| Affiliation |
AIIMS RAIPUR |
| Address |
Seminar Room Paediatrics Department AIIMS,Raipur
Seminar Room Paediatrics Department AIIMS,Raipur
Raipur
CHHATTISGARH
492010
India |
| Phone |
8413994107 |
| Fax |
|
| Email |
vijaylakshmichongtham171@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ATUL JINDAL |
| Designation |
Additional Professor |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of Paediatrics,AIIMS,Raipur
Department of Paediatrics,AIIMS,Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8224014667 |
| Fax |
|
| Email |
dratuljindal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR CHONGTHAM VIJAYLAXMI DEVI |
| Designation |
PG JUNIOR RESIDENT |
| Affiliation |
AIIMS RAIPUR |
| Address |
Seminar Room Department of Paediatrics,AIIMS,Raipur
Seminar Room Department of Paediatrics,AIIMS,Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8413994107 |
| Fax |
|
| Email |
vijaylakshmichongtham171@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics,All India Institute of Medical Sciences ,Raipur(Chhattisgarh) |
|
|
Primary Sponsor
|
| Name |
Department of Pediatrics All India Institute of Medical Sciences Raipur |
| Address |
All India Institute of Medical Sciences,Raipur(Chhattisgarh),Tatibandh,GE Road,Raipur 492099 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DR CHONGTHAM VIJAYLAXMI DEVI |
AIIMS RAIPUR |
Seminar room, department of paediatrics, AIIMS , Raipur
Raipur
CHHATTISGARH |
8413994107
vijaylakshmichongtham171@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS Raipur Chhattisgarh |
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 |
Study drug A |
Drug A: Dexamethasone 0.3 mg/kg/day/i.v with 5ml 0.9% Normal saline for 5 days(5 doses in total) |
| Comparator Agent |
Study drug B |
5ml, 0.9% normal saline, i.v, per day for 5 days |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
Children diagnosed with acute bronchiolitis meeting the clinical diagnosis of moderate and severe bronchiolitis to age group 1month to less than and equal to 2years within 10days of onset of illness admitted to in patient department of paediatrics in AIIMS ,Raipur |
|
| ExclusionCriteria |
| Details |
1 if the onset illness is more than 10days
2 if the child had received any form of steroids from outside hospital
3 if there is denial for informed consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Resolution of fever and tachypnea
2.Liberation from respiratory support
3.Reduction in duration of hospital stay |
5 days after initiation of the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Need for invasive mechanical ventilation
2. Need for new respiratory support
3. Duration of nebulisation requirement
4. Duration of antibiotics if used
5. Any adverse effect to dexamethasone
6. Readmission with same symptoms |
5 days after initiation of intervention |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
Final Enrollment numbers achieved (Total)= "116"
Final Enrollment numbers achieved (India)="116" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/03/2024 |
| Date of Study Completion (India) |
30/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/04/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study design has not been done among the children age group between 1month to less than and equal to 2 years according to the published literatures that I have come across in my review of literature.keeping this idea behind I planned to conduct this experimental study to give new knowledge to the scientific community . |