| CTRI Number |
CTRI/2025/03/083536 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Clinical profile of children with acute encephalitis syndrome |
|
Scientific Title of Study
|
Clinical profile of children admitted with acute encephalitis syndrome in a tertiary care center : A cross sectional 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 UMA MAHESH |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room no. 3012, Department of Pediatrics, Rohilkhand Medical College, Pilibhit bypass road, Bareilly.
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9381101231 |
| Fax |
|
| Email |
UMAMAHESHPALLEBOINA@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHIVANI BANSAL |
| Designation |
ASSOCIATE PROFFESSOR |
| Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room no. 3012, Department of Pediatrics, Rohilkhand Medical College, Pilibhit bypass road, Bareilly.
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8077948719 |
| Fax |
|
| Email |
Shivanibansal1305@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR UMA MAHESH |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room no. 3012, Department of Pediatrics, Rohilkhand Medical College, Pilibhit bypass road, Bareilly.
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9381101231 |
| Fax |
|
| Email |
UMAMAHESHPALLEBOINA@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Room no. 3012, Department of Pediatrics, Rohilkhand Medical College, Pilibhit bypass road, Bareilly 243006, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
DR UMA MAHESH |
| Address |
Room no. 3012, Department of Pediatrics, Rohilkhand Medical College, Pilibhit bypass road, Bareilly. |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DR UMA MAHESH |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
Room No. 3012, Department of Pediatrics, Rohilkhand Medical College, Pilibhit bypass road, Bareilly.
Bareilly
UTTAR PRADESH |
9381101231
UMAMAHESHPALLEBOINA@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
6.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children of age group between 6 months to 18 years.
Children who are admitted with clinical features of Acute encephalitis syndrome as per WHO Protocol |
|
| ExclusionCriteria |
| Details |
Children admitted in Pediatric intensive care unit with clinical features of Intra cranial haemorrage , Trauma, Tumors, Poisoning.
Children who are having developmental delay due to any other causes. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the Clinical profile of children with Acute encephalitis syndrome (AES) |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate the prevalence of Acute encephalitis syndrome in children aged 6 months-18 years .
To study the clinical presentation of acute encephalitis syndrome in children aged 6 months-18 years .
|
At baseline |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
01/04/2025 |
| 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
|
All children who are suspected to have AES (Acute
encephalitis syndrome) and admitted in pediatric intensive care unit, the
following steps will be conducted:
Proforma with complete history, vitals, clinical findings of
CNS, duration of admission and drugs received.
Complete blood
picture, Blood culture and sensitivity, CRP, Electrolytes, Calcium, LFT and KFT
will be sent.
Lumbar punture will be done and CSF analysis sent for
cytobiology, ZN staining/AFB, gram staining, CBNAAT and virology study.
EEG
MRI and if required MRI with contrast.
Patients with diagnosis of acute encephalitis syndrome will
be managed as per AES protocol with appropriate antibiotics and supportive
therapy.
Complications if any shall be noted and appropriate measures
will be taken to treat them. |