| CTRI Number |
CTRI/2021/05/033503 [Registered on: 10/05/2021] Trial Registered Prospectively |
| Last Modified On: |
09/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Clinical profile and outcome in children with Acute Encephalitis syndrome(brain fever ) -A prospective study |
|
Scientific Title of Study
|
Clinical profile and outcome in children with Acute Encephalitis Syndrome (AES) -a prospective study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
P ASWINI |
| Designation |
Junior resident |
| Affiliation |
Kasturba medical college |
| Address |
Department of Paediatrics
Kasturba Medical College
Udupi
KARNATAKA
576104
India |
| Phone |
8464935222 |
| Fax |
|
| Email |
reddyaswini34@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrikiran A |
| Designation |
Professor and head of unit , Department of paediatrics |
| Affiliation |
Kasturba medical college |
| Address |
Department of Paediatrics
Kasturba medical college
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448177671 |
| Fax |
|
| Email |
Shrikiran.a@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Kumar BK |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba a medical collge |
| Address |
Department of Paediatrics
Kasturba medical college
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8197120018 |
| Fax |
|
| Email |
kumar.sandeep@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,Manipal |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| P Aswini |
Kasturba medical college ,Manipal |
Department of Pediatrics
Kasturba Medical college
Manipal
Udupi
KARNATAKA |
8464935222
reddyaswini34@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and kasturba hospital ,Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G049||Encephalitis, myelitis and encephalomyelitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All children 1 month to 18 yrs old diagnosed with Acute Encephalitis Syndrome in Kasturba hospital,Manipal |
|
| ExclusionCriteria |
| Details |
1. Toxic Encephalopathy
2.Hypertensive Encephalopathy
3.Major congenital anamoliespredisposing to infection .Eg Spina bifida,Meningocele,CSF Rhinorrhoea
4.History of head injury
5Inborn Errors of metabolism |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Vision
2.Hearing
3.Seizures
4.Glasgow coma scale
5.Neurodeficits
6.Discharged /Death |
Outcome assessed at discharge and at first follow up in 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
12/05/2021 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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)?
Response - NO
|
|
Brief Summary
|
Acute Encephalitis syndrome (AES ) posses a great public in India occurring both epidemics and sporadically .Although JE was know to be main cause of AES in India and was often paralleled with AES, studies conducted shows a shift in perception of etiology of AES in INDIA which is vey wide and often the cause reminds unknown . This is prospective observational study to be conducted in Kasturba Hospital ,Manipal.All cases admitted with symptoms suggestive of AES will be included in the study after application of inclusion and exclusion criteria .Detailed clinical examination and investigations done as a part of standard care will be documented, entered in predetermined proforma .Details of treatment and hospital course will be included and outcome will be measured at the discharge and at 3 month follow up. |