| CTRI Number |
CTRI/2014/08/004813 [Registered on: 04/08/2014] Trial Registered Retrospectively |
| Last Modified On: |
31/07/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective analysis |
| Study Design |
Other |
|
Public Title of Study
|
Kerosene poisoning in Children |
|
Scientific Title of Study
|
A retrospective study of outcome in children with Kerosene consumption |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Guruswamy NT |
| Designation |
Post Graduate Resident |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Pediatrics
Father Muller Medical college
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
09448988990 |
| Fax |
|
| Email |
guru254888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrHabib Khan |
| Designation |
Associate Professor |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Pediatrics
Father Muller Medical college
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
09008819377 |
| Fax |
|
| Email |
habibkhans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrHabib Khan |
| Designation |
Associate Professor |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Pediatrics
Father Muller Medical college
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
09008819377 |
| Fax |
|
| Email |
habibkhans@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical college |
|
|
Primary Sponsor
|
| Name |
Father Muller Medical College |
| Address |
Father Muller Medical College
Kankanady
Mangalore-575002
Dakshina Kannada
Karnataka |
| Type of Sponsor |
Private 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 |
| DrGuruswamy NT |
Dept of pediatrics and Medical records department,Father Muller Medical college Hospital |
Father Muller Medical college Kankanady
Mangalore-575002
Dakshina Kannada
KARNATAKA |
09448988990
guru254888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Children below 5 years admitted with Kerosene consumption , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children below 5 years admitted in Fr Muller Medical College Hospital with Kerosene consumption from April 2010 to March 2013 |
|
| ExclusionCriteria |
| Details |
Children above 5 years with kerosene consumption |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To explore symptoms and signs morbidity,mortality associated with kerosene poisoning |
To explore symptoms and signs morbidity,mortality associated with kerosene poisoning on day of admission and before discharge/death |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To explore morbidity and mortality associated with kerosene poisoning |
From admission to discharge |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/08/2014 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
SOURCE OF DATA :
Medical records of children admitted to Fr Muller Medical
College Hospital with Kerosene consumption during the 3 year period starting from April 2010 to March 2013 will
be reviewed.
Method
of collection of data
Children below 5 years
admitted in Fr Muller Medical College Hospital with Kerosene consumption from April 2010 to March 2013 will form the study
population. The
clinical data of these children will be obtained from the Medical Records Department of Father Muller
Medical College Hospital.
Information obtained include:
·
their
age
·
their
sex
·
the
mode and route of poisoning (i.e. ingestion or otherwise)
·
whether
the poisoning was unintentional or deliberate
·
the quantity consumed
·
Respiratory symptoms-onset, course and
recovery
·
CNS symptoms-onset, course and
recovery
·
Any other morbidity / association
Statistical Analysis :
Collected data
will be analysed by frequency,
percentage and by Chi-square test
|