| CTRI Number |
CTRI/2024/06/068708 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Pneumonia in Children aged 1 month to 5 years |
|
Scientific Title of Study
|
Study of Pneumonia in Children aged 1 month to 5 years |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Shrivastava |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Pediatrics, Kasturba Hospital, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
7760116902 |
| Fax |
|
| Email |
sakshi.s.shrivastava@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Bhat Y |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Pediatrics, Kasturba Hospital, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9686401313 |
| Fax |
|
| Email |
ramesh.bhaty@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
ANAND KUMAR PATIL |
| Designation |
Senior resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Pediatrics, Kasturba Hospital, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8147205248 |
| Fax |
|
| Email |
anandkumar.patil@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics, Kasturba Hospital, Manipal, Udupi |
|
|
Primary Sponsor
|
| Name |
Dr Sakshi Shrivastava |
| Address |
Department of Pediatrics, Kasturba Hospital, Manipal, Udupi |
| 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 |
| DR SAKSHI SHRIVASTAVA |
KASTURBA HOSPITAL |
Department of Pediatrics, Kasturba Hospital, Manipal, Udupi
Udupi
KARNATAKA |
7760116902
sakshi.s.shrivastava@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Hospital Institutional Ethics ComitteeMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J09-J18||Influenza and pneumonia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Day(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 1 month to 5 years admitted in the Department of Paediatrics with clinical diagnosis of pneumonia and suggestive chest x-ray findings. |
|
| ExclusionCriteria |
| Details |
Children with diagnosis of bronchial asthma, aspiration pneumonia/ventilator associated pneumonia, pulmonary tuberculosis, pneumonia secondary to foreign body inhalation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Requirement of Oxygen supplementation and duration
If Pleural effusion- Pleural tap/ ICD insertion and duration
Length of ICU stay
Length of hospital stay
|
at baseline, 1 days, 3 days, 5 days,7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "334"
Final Enrollment numbers achieved (India)="334" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/06/2024 |
| Date of Study Completion (India) |
31/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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)
|
Ethical clearance will be obtained from the Institutional ethical committee. CTRI approval will be taken before the commencement of the study. An informed consent will be taken by the parents of the children included in the study. Demographic data, associated risk factors, birthweight/gestation at birth, exposure to indoor/outdoor pollution, underlying co-morbidities, nutritional state will be collected according to the proforma designed for the study. PRESS score and pneumonia classification according to ARI control programme will be determined at the time of admission. Chest x-ray findings will be collected. If other imaging is done, details will be collected. The clinical profile of the child will be studied for associated risk factors and analyzed using appropriate statistical test. |