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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  acute lower respiratory tract infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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. 
 
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