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CTRI Number  CTRI/2024/05/067396 [Registered on: 15/05/2024] Trial Registered Prospectively
Last Modified On: 14/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Screening 
Study Design  Other 
Public Title of Study   To Assess Knowledge And Practice of Child Restraint System during transportation in car among parents of children aged below 5 years 
Scientific Title of Study   Knowledge and Practice of Child restraint system during transportation in car among parents of children aged below 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  Dr P N VISHNU TEJA 
Designation  Junior resident Department of Paediatrics 
Affiliation  Kasturba medical college mangalore 
Address  Kasturba Medical College Light house hill road Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  8374006859  
Fax    
Email  vishnutejapenujuri@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Major Rajesh S M  
Designation  Professor Department of Paediatrics 
Affiliation  Kasturba medical college mangalore 
Address  Kasturba Medical College Department of Pediatrics Light house hill road Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9343434344  
Fax    
Email  majorrajeshsm@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Major Rajesh S M  
Designation  Professor Department of Paediatrics 
Affiliation  Kasturba medical college mangalore 
Address  Kasturba Medical College Department of Pediatrics Light house hill road Mangalore


KARNATAKA
575001
India 
Phone  9343434344  
Fax    
Email  majorrajeshsm@yahoo.co.in  
 
Source of Monetary or Material Support  
KMC Hospital Attavar, Nandigudda road, Attavar, Mangalore 575002 
 
Primary Sponsor  
Name  Dr P N VISHNU TEJA 
Address  Kasturba Medical College, light house hill road, Mangalore-575001, Karnataka 
Type of Sponsor  Other [self] 
 
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 P N Vishnu Teja  KMC Hospital, ATTAVAR  Room no 17, Pediatrics opd, 1st floor, Department of Pediatrics, KMC Hospital, Attavar, Mangalore-575001, Dakshina Kannada, Karnataka, India
Dakshina Kannada
KARNATAKA 		 8374006859

vishnutejapenujuri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Medical College, Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Factors influencing knowledge and practice of child restraint system  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Knowledge based Intervention   Parents of children aged below 5 years are provided knowledge about child restraint system via flipcharts containing pictures and text about child restraint system and reassess practice after 1 month 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  5.00 Year(s)
Gender  Both 
Details  All parents of children below 5 years who are using four wheeler and who agrees to give consent to participate 
 
ExclusionCriteria 
Details  Children with physical disabilities
Children with orthopaedic problems
Children going to special schools. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Knowledge and practice will be assessed with help of questionnaire and will be followed up for practice of using car restraint system after 1 month
 		 Knowledge and practice will be assessed with help of questionnaire and will be followed up for practice of using car restraint system after 1 month
 
 
Secondary Outcome  
Outcome  TimePoints 
To know the proportion of parents using child restaint system  Practice will be assessed with help of questionnaire at the start of the study & at 4 weeks. 
 
Target Sample Size   Total Sample Size="326"
Sample Size from India="326" 
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)   25/05/2024 
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 Applicable 
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   Child restraint system are seats specifically designed to protect children from injury during transportation in a motor vehical crash. Road traffic accidents are one of the major causes of injuries and death of children. According to Government of INDIA MINISTRY OF ROAD TRANSPORT AND HIGHWAYS in the year 2021 a total number of 412432 road accidents have been reported in the country, claiming lives of 153972 people, and causing injuries to 384448 persons. India has second largest road network in the world of about 63.72 lakh kms. In this study parents of children below 5 years of age will be approached and their baseline knowledge and practice of using child restraint system will be assessed with the help of questionnaire and will be followed up after 1 month to assess the practice of using the child restraint systems.   
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