| CTRI Number |
CTRI/2012/04/002598 [Registered on: 24/04/2012] Trial Registered Retrospectively |
| Last Modified On: |
27/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Admission predictors of children with fever , cough and breathing difficulty |
|
Scientific Title of Study
|
Clinical predictors of hospital admission in children with acute lower respiratory tract infection |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
vidushi mahajan |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Sector 32 |
| Address |
Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
9646121531 |
| Fax |
|
| Email |
vidushimahajan2003@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
vidushi mahajan |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Sector 32 |
| Address |
Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
9646121531 |
| Fax |
|
| Email |
vidushimahajan2003@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
vidushi mahajan |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Sector 32 |
| Address |
Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
9646121531 |
| Fax |
|
| Email |
vidushimahajan2003@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Science and Technology, Chandigarh Administration, Addditional Town Hall Building, 2nd floor, Sector 17 C,Chandigarh-160017 |
|
|
Primary Sponsor
|
| Name |
Director Principal |
| Address |
Govt. Medical College and Hospital, Sector 32,Chandigarh. |
| 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 Vidushi Mahajan |
Pediatrics department, Goverment Medical College and Hospital |
Sector 32, Chandigarh Chandigarh CHANDIGARH |
9646121531
vidushimahajan2003@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College ,Sector 32, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
acute lower respiratory tract infection, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Month(s) |
| Age To |
59.29 Month(s) |
| Gender |
Both |
| Details |
ALL CHILDREN WITH ACUTE LOWER RESPIRATORY TRACT INFECTION (ALRTI) |
|
| ExclusionCriteria |
| Details |
1) Lethal malformations
2) Chronic suppurative lung disease
3) Nosocomial pneumonia
4)cough for more than 3 weeks
5) h/o contact with active pulmonary tuberculosis
6)pneumonia secondary to measles and whooping cough
7) asthma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Need for hospital admission |
from presentation till discharge/ death whichever is earlier |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) death
2)need for ventilatory and/or ionotropic support |
from presentation till discharge/ death |
|
|
Target Sample Size
|
Total Sample Size="260" Sample Size from India="260"
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)
|
15/12/2011 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Summary:
This is an prospective observational study1) To know the profile of children presenting to Pediatric emergency department with acute lower respiratory tract infection(ALRI) (2) To identify the risk factors which predict hospital admission in children with acute lower respiratory tract infection (3) To develop clinical score based on the above risk factors which help to predict hospitalisation. ALRI has a spectrum of presentation including pneumonia, brochiolitis, acute laryngo-tracheo-bronchitis with a spectrum of clinical severity. The decision whether ALRI should be treated in hospital or in the community is a difficult one. Severity scores have been promoted as useful tools to augment clinical judgement. The predictive scores have been designed for the pneumonia and Bronchiolitis, however in the absence of chest x-ray, broad term ALRI is used. Scores for ALRI determining hospital admission are non-existant. The present study is designed to develop a simple scoring system for prediction of hospitalization among children presenting with ALRI. Our primary outcome measures are need for hospital admission. Our secondary outcome measure will be death and need for ventilatory or inotropic support. The end point of the study is when the patient is discharged alive or died. |