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CTRI Number  CTRI/2024/06/068639 [Registered on: 10/06/2024] Trial Registered Prospectively
Last Modified On: 09/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study of Intentional self harm in children - Observing real life trends 
Scientific Title of Study   Study of Intentional self harm in children - A prospective observational study 
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 Karen Janice Moras 
Designation  MD Paediatrics, Associate professor , Department of Paediatrics 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Paediatrics, Kasturba Medical College, MAHE, Manipal, Udupi, Karnataka Kasturba Medical College, MAHE, Manipal, Udupi, Karnataka Udupi KARNATAKA 576104 India

Udupi
KARNATAKA
576104
India 
Phone  9980782769  
Fax    
Email  alliswell274@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nikhil N Nayak 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Paediatrics, Kasturba Medical College, MAHE, Manipal, Udupi, Karnataka Kasturba Medical College, MAHE, Manipal, Udupi, Karnataka Udupi KARNATAKA 576104 India

Udupi
KARNATAKA
576104
India 
Phone  8073359376  
Fax    
Email  nikhil.kmcmpl2023@learner.manipal.edu  
 
Details of Contact Person
Public Query  
Name  Leslie Edward S Lewis 
Designation  MD Paediatrics, Professor and HOD, Department of Paediatrics 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Paediatrics, Kasturba Medical College, MAHE, Manipal, Udupi, Karnataka Kasturba Medical College, MAHE, Manipal, Udupi, Karnataka Udupi KARNATAKA 576104 India

Udupi
KARNATAKA
576104
India 
Phone  9449208476  
Fax    
Email  leslie.lewis@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, MAHE, Manipal, Udupi, Karnataka, India 576104 
 
Primary Sponsor  
Name  Not applicable 
Address  Not applicable 
Type of Sponsor  Other [Not applicable] 
 
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 Karen Janice Moras  Department of Paediatrics, Kasturba Medical College and Hospital Manipal 576104  2nd floor, Paediatric Wards & PICU, Women and Children block, Department of Paediatrics, Kasturba Medical College, Madhav Nagar, Manipal 576104 Udupi KARNATAKA
Udupi
KARNATAKA 		 9980782769

alliswell274@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Hospital, Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children aged 10 to 18 years admitted in the department of Paediatrics in KMC Manipal with
intentional self- harm 
 
ExclusionCriteria 
Details  Accidental- Drug overdose/Exposure to harmful substances 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To identify risk factors contributing to self-harm in children  Within 72 hours of admission 
 
Secondary Outcome  
Outcome  TimePoints 
To study the Social, Child related factors & Family related factors contributing to intentional self-harm in children  Within 72 hours of admission 
To study the in-hospital outcome of children: death/ survival/ disability  At the time of discharge/death
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   20/06/2024 
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="6"
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   Children of age 10 to 18 years with history of poisoning /self- harm  will be interviewed and later after interviewing, the cases with intentional self-harm will be taken up for the study, The patients will be recruited from children admitted in PICU & Wards under Department of Pediatrics, KMC Manipal. Ascent from the child along with informed consent from the parent would be taken, Detailed Socio-demographic history will be taken and possible risk factors in household, school, family and children which led to intentional self-harm will be noted. General physical examination and relevant systemic examination will be noted. The clinical examination will be done within 72 hours of admission. Relevant laboratory investigations will be done to look for organ damage• Outcomes of intentional self-harm in the form of days of PICU stay, mechanical ventilation, neuro-deficits and death, survival will be noted. Descriptive statistics will be recorded to produce tabulated percentages, mean , median & range of variables. Chi square test, Fisher Exact test & Mann Whitney test maybe used to test the association/comparison among categorical variables. Binary logistic regression will be used to study the association between time of presentation & age, gender, associated morbidity. 
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