| CTRI Number |
CTRI/2019/05/019334 [Registered on: 24/05/2019] Trial Registered Prospectively |
| Last Modified On: |
25/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
Identify the percentage in type of pneumonia and related factors among children. |
|
Scientific Title of Study
|
A retrospective study to compute the prevalence and its associated risk factors of pneumonia among children at selected tertiary care hospital,kancheepuram district,Tamilnadu,India. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JEGIN P |
| Designation |
Bsc Nursing pre final student |
| Affiliation |
CHETTINAD ACADEMY OF RESEARCH AND EDUCATION |
| Address |
CHETTINAD COLLEGE OF NURSING,
CHETTINAD ACADEMY OF RESEARCH AND EDUCATION,
RAJIV GANDHI SALAI,
KELAMBAKKAM.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
7401491419 |
| Fax |
|
| Email |
pjegin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SUBBULAKSHMI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
CHETTINAD ACADEMY OF RESEARCH AND EDUCATION |
| Address |
ROOM NO 3,
DIVISION 3,
CHETTINAD COLLEGE OF NURSING,
CHETTINAD ACADEMY OF RESEARCH AND EDUCATION,
RAJIV GANDHI SALAI,
KELAMBAKKAM.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9944592175 |
| Fax |
|
| Email |
kbsubbulakshmi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
JEGIN P |
| Designation |
Bsc Nursing pre final student |
| Affiliation |
CHETTINAD ACADEMY OF RESEARCH AND EDUCATION |
| Address |
CHETTINAD COLLEGE OF NURSING,
CHETTINAD ACADEMY OF RESEARCH AND EDUCATION,
RAJIV GANDHI SALAI,
KELAMBAKKAM.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
7401491419 |
| Fax |
|
| Email |
pjegin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Academy of Research and Education,Rajiv Gandhi salai,Kelambakkam,Kancheepuram,Tamilnadu,India. |
|
|
Primary Sponsor
|
| Name |
CHETTINAD ACADEMY OF RESEARCH AND EDUCATION |
| Address |
RAJIV GANDHI SALAI,
KELAMBAKKAM,
KANCHEEPURAM,
TAMILNADU,
INDIA |
| 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 |
| Mrs Subbulakshmi |
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE |
CHETTINAD ACADEMY OF RESEARCH AND EDUCATION, RAJIV GANDHI SALAI, KELAMBAKKAM, KANCHEEPURAM,TAMILNADU
Kancheepuram
TAMIL NADU |
9944592175
kbsubbulakshmi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J189||Pneumonia, unspecified organism, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
The study includes the medical record data on
1. data on children from 0 to 18 years,
2. data for the period of January 2017 to December 2018. |
|
| ExclusionCriteria |
| Details |
The study excludes the
1.data for the children with other lower respiratory tract infection. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The research project will provide the statistical data on prevalence of Pneumonia and associated factors among children. |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| which enables the future researchers to conduct evidenced based research. |
1 week |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 1 |
|
Date of First Enrollment (India)
|
25/06/2019 |
| 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="0"
Months="9"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Study data collection not yet started so no publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A retrospective study to compute the prevalence and its associated risk factors of pneumonia among children at selected tertiary care hospital,kancheepuram district,Tamilnadu,India.-[Pneumonia] objectives are to determine the incidence of pneumonia among children, to estimate the types of pneumonia among children with pneumonia, to find out the association between the pneumonia and the selected risk factors of children.
|