| CTRI Number |
CTRI/2025/07/091480 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study how children immune systems react to serious chest infections |
|
Scientific Title of Study
|
Immunological profile of children with empyema thoracis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Simran Dhamija |
| Designation |
Post GraduateResident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department Of Pediatrics
Maulana Azad Medical College
New Delhi
110002
India
Central
DELHI
110002
India |
| Phone |
9891536241 |
| Fax |
|
| Email |
simrandhamija03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Monica Juneja |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department Of Pediatrics
Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9968604311 |
| Fax |
|
| Email |
drmonicajuneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Simran Dhamija |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department Of Paediatrics
Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
09891536241 |
| Fax |
|
| Email |
simrandhamija03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Paediatrics,Maulana Azad Medical College,Delhi,India
Pin Code-110002 |
|
|
Primary Sponsor
|
| Name |
Department of Paediatrics |
| Address |
Maulana Azad Medical College,Delhi,India
Pin Code-110002 |
| 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 |
| Simran Dhamija |
Lok Nayak Hospital |
Ward 15,Department of Pediatrics
Central
DELHI |
9891536241
simrandhamija03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J869||Pyothorax without fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with empyema thoracis confirmed on pleural tap as per British thoracis guidelines |
|
| ExclusionCriteria |
| Details |
Children who have received intravenous immunoglobulins in last 3 months
Children who have received blood products in last 3 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of children with B cell defects |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of children with empyema thoracis with
T cell,natural killer cell & leucocyte adhesion deficiency defect
Secondary causes of immunodeficiency like malnutrition,human immunodeficiency virus,chronic disorders like chronic liver disease,chronic kidney disease |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
03/08/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
This study is an observational study to find out the immunological status of children with empyema thoracis aged 2 months to 12 years in 75 patients to be conducted in department of paediatrics in Maulana Azad Medical College,New Delhi. The primary outcome will be to find out the b cell defects in children aged 2 months to 12 years The secondary outcome will be to find out the T cell defects,natural killer cell defects and leucocyte adhesion defects and secondary causes of immunodeficiency like malnutrition,human immunodeficiency virus,chronic disorders like chronic liver disease,chronic kidney disease |