| CTRI Number |
CTRI/2025/09/094073 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of steroid in care of children admitted with Acute respiratory distress syndrome in reducing hospital stay |
|
Scientific Title of Study
|
Effect of Methylprednisolone in Paediatric Acute Respiratory Distress Syndrome in addition to standard care on length of hospital stay |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sudha Chandelia |
| Designation |
Associate professor |
| Affiliation |
ABVIMS and Dr RML hospital, delhi |
| Address |
Room no. 403, Admin block,PGI Building, ABVIMS and Dr. RML hospital,New delhi
PICU,ECS 4th floor, Department of Paediatrics, ABVIMS and Dr. RML Hospital, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
7982425172 |
| Fax |
|
| Email |
sudhach83@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sudha Chandelia |
| Designation |
Associate professor |
| Affiliation |
ABVIMS and Dr RML hospital, delhi |
| Address |
Room no. 403,Admin block, PGI building, ABVIMS and Dr RML Hospital, Baba Kharak singh road, Cannaught Place, New Delhi
New doctors hostel, room 1218B, Dr RML Hospital, New delhi
New Delhi
DELHI
110001
India |
| Phone |
7982425172 |
| Fax |
|
| Email |
sudhach83@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varsha |
| Designation |
Post Graduate student |
| Affiliation |
ABVIMS and Dr RML hospital, delhi |
| Address |
PICU, ECS 4TH FLOOR, Department of Paediatrics, Dr Ram Manohar Lohia Hospital, Baba kharak singh road, Cannaught Place, New Delhi
Room no. 1105B , New doctors hostel, Dr Ram manohar lohiya hospital, New delhi
New Delhi
DELHI
110001
India |
| Phone |
08708281379 |
| Fax |
|
| Email |
varshay657@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr. RML Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr RML hospital |
| Address |
Baba Kharak Singh Road, Cannaught Place,New Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 Varsha |
ABVIMS and Dr. RML hospital |
Baba Kharak singh road, Cannaught place, New Delhi
New Delhi
DELHI |
08708281379
varshay657@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ABVIMS, Dr. RML Hospital, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J80||Acute respiratory distress syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Methylprednisolone infusion |
Methylprednisolone will be used as an intervention medication. Dose of Methylprednisolone will be reconstituted in 50ml Normal saline with a final strength of 2mg/ml and will be given through infusion pump using 50ml syringe (Rate will be volume half of the weight of the child given over 24 hrs)
Dose: 1mg/kg over 24 hours for 7days
0.5mg/kg over 24 hours for day 8-10 day
0.25mg/kg over 24 hours for 11-12 days
0.125mg/kg over 24 hours for 13-14 days and stop
If the child is extubated successfully (No need for mechanical ventilation for 48 hours) extubated before day 14 , we will start tapering and stop.
.
|
| Comparator Agent |
Normal saline |
Normal saline supplied from Department of Pharmacology with a label of alpha numerical code reconstituted in 50ml syringes |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group: 1month -18years
2. Diagnosis of ARDS based on PALICC 2 consensus guidelines
3. Mechanically ventilated for less than 72 hrs.
|
|
| ExclusionCriteria |
| Details |
1. Patients receiving steroids already
2. Terminally ill or on hospise care
3. Immunosuppressed
4. Extensive burns
5. Adrenal insufficiency
6. Invasive fungal infection
7. Chronic liver disease
8. Gastrointestinal bleed in past 1 month
|
|
|
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 |
| Length of hospital stay |
date of discharge from hospital-date of randomisation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ventilator free days
2. Length of PICU stay
3. 28 day’s mortality |
28 days – date of extubation |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="2"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [varshay657@gmail.com].
- For how long will this data be available start date provided 11-11-2025 and end date provided 11-11-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
After obtaining Institutional Ethics Committee approval and written informed consent from the patients, 28 patients per group will be enrolled for the study. Screening will be done using a predesigned proforma for elegibiltiy of the child for inclusion in the study. If the child is elegible for study, consent will be obtained and the child will be randomly assigned to one of the study intervention, study intervention will be started and data will be collected. |