| CTRI Number |
CTRI/2019/04/018427 [Registered on: 05/04/2019] Trial Registered Prospectively |
| Last Modified On: |
03/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Identity the percentage of fits due to fever and related factors among children |
|
Scientific Title of Study
|
"Assessment of the prevalence of febrile seizure and associated factors among children- A Retrospective study" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jisha L |
| Designation |
Bsc Nursing pre final student |
| Affiliation |
Chettinad Academy Of Research and Education |
| Address |
Chettinad College Of Nursing,Chettinad Academy Of Research and Education, Chettinad University,Rajiv Gandhi Salai,kelambakkam.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9087357714 |
| Fax |
|
| Email |
jittujisha98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kogila P |
| Designation |
Associate Professor |
| Affiliation |
Chettinad Academy Of Research and Education |
| Address |
Room no-3,devision-3,Chettinad College Of Nursing,Chettinad Academy Of Research and Education, Chettinad University,Rajiv Gandhi Salai,kelambakkam.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9791868988 |
| Fax |
|
| Email |
kogipalani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jisha L |
| Designation |
Bsc Nursing pre final student |
| Affiliation |
Chettinad Academy Of Research and Education |
| Address |
Chettinad College Of Nursing,Chettinad Academy Of Research and Education, Chettinad University,Rajiv Gandhi Salai,kelambakkam.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9087357714 |
| Fax |
|
| Email |
jittujisha98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Academy of Research and Education,Rajiv Gandhi Salai,Kelambakkam,Kancheepuram,Tamilnadu,India. |
|
|
Primary Sponsor
|
| Name |
Chettinad Academy Of Research and Education |
| Address |
Rajiv Gandhi Salai,Kancheepuram,Tamilnadu, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Mrskogila p |
Chettinad Hospital And Research Institute |
Chettinad Hospital And Research Institute,Chettinad Academy of Research and Education,Rajiv Gandhi Salai,Kelambakkam,Kancheepuram,Tamilnadu.
Kancheepuram
TAMIL NADU |
9791868988
kogipalani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G408||Other epilepsy and recurrent seizures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
The researcher plans to collect the data between January 2018 to December 2018.
Prior permission and consent will be obtained from Medical Record Department before conducting the study. Permission to pursue the Medical Record Department document for specified data will be obtained from the Dean, CHRI. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
The study includes medical records data on
1.Febrile seizure and associated
factors from January 2018 to December
2018
2.Children with 0-6 years
3.Both male and female |
|
| ExclusionCriteria |
| Details |
The study excludes data on
1.Non febrile Seizure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The research project will provide the statistical data on prevalence of Febrile seizure and associated factors among children |
1week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Which enables the future researchers to conduct evidenced based research.
|
1 week |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
06/04/2019 |
| 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="0"
Months="9"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Assessment on prevalence of febrile seizures and associated factors among children -A retrospective study planned . The objectives are to assess the prevalence and types of febrile seizures among children and to find out the relationship between febrile seizures and selected associative factors.The outcome of research project is provide the statistical data on prevalence of febrile seizures and associated factors among children, which enables the future researchers to conduct evidenced based research. |