| CTRI Number |
CTRI/2025/02/080876 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
STUDY TO CHECK HEARING LOSS IN CHILDREN WITH NEPHROTIC SYNDROME |
|
Scientific Title of Study
|
TO STUDY ASSOCIATION BETWEEN CHILDREN WITH NEPHROTIC SYNDROME AND HEARING LOSS: 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 SHREYANSHI GUPTA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
DEPARTMENT OF OTO-RHINO-LARYNGOLOGY AND HEAD AND NECK SURGERY, KMC MANIPAL, MADHAV NAGAR, EESHWAR NAGAR, UDUPI, KARNATAKA
Udupi
KARNATAKA
576104
India |
| Phone |
7055228246 |
| Fax |
|
| Email |
guptashreyanshi07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AJAY BHANDARKAR |
| Designation |
|
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
DEPARTMENT OF OTO-RHINO-LARYNGOLOGY AND HEAD AND NECK SURGERY, KMC MANIPAL, MADHAV NAGAR, EESHWAR NAGAR, UDUPI, KARNATAKA
Udupi
KARNATAKA
576104
India |
| Phone |
9845144015 |
| Fax |
|
| Email |
bm.ajay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHREYANSHI GUPTA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
DEPARTMENT OF OTO-RHINO-LARYNGOLOGY AND HEAD AND NECK SURGERY, KMC MANIPAL, MADHAV NAGAR, EESHWAR NAGAR, UDUPI, KARNATAKA
Udupi
KARNATAKA
576104
India |
| Phone |
7055228246 |
| Fax |
|
| Email |
guptashreyanshi07@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAHE GRANT, KASTURBA HOSPITAL, MAHE , MANIPAL, KARNATAKA, INDIA |
|
|
Primary Sponsor
|
| Name |
MAHE KASTURBA HOSPITAL |
| Address |
KASTURBA HOSPITAL, MAHE, MANIPAL, KARNATAKA, INDIA |
| 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 |
| DR SHREYANSHI GUPTA |
DEPARTMENT OF ENT, 4TH FLOOR, NEW OPD BLOCK, KASTURBA HOSPITAL, MANIPAL |
KASTURBA HOSPITAL, MADHAV NAGAR, MANIPAL, UDUPI DISTRICT, KARNATAKA, INDIA
Udupi
KARNATAKA |
7055228246
guptashreyanshi07@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-2 (student research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N04||Nephrotic syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed cases of Idiopathic Nephrotic Syndrome
2. Age 2 to 12 years |
|
| ExclusionCriteria |
| Details |
1. Age less than 2 year and more than 12 year
2. Children with congenital hearing loss
3. Children of Nephrotic syndrome associated with hearing loss secondary to ASOM/CSOM and ear trauma or surgical interventions related to hearing
4. Children with previously known hearing impairment
5. Children with any other medical or surgical illness causing hearing impairment
6. Patients with known comorbidities
7. Children with history of Acute febrile illness (Meningitis, Encephalitis, etc)
8. Children with history of ear infection with history of Ototoxic drug intake
9. nephrotic patients with renal insufficiency
10. children with known neurological disorders that may affect hearing
11. children with cognitive impairment, language barrier
12. Refusal or Inability to Provide Informed Consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of hearing loss in children diagnosed with Nephrotic syndrome using Chirp ABR (Chirp- Auditory brainstem response) and TP-OAE (Transitory evoked otoacoustic emission.
|
24/02/2025 TO 01/03/2026
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Evaluation hearing loss in primary (newly diagnosed) cases & cases on multiple relapses (steroid dependent) in children with Nephrotic Syndrome.
2) Correlation of the dose of steroids with the occurrence of hearing loss in different severity. |
24/02/2025 TO 01/03/2026 |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
24/02/2025 |
| 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="1"
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
|
1. source of data: data will be collected from OP/IP patients attending Department of Pediatrics and Department of Pediatric Nephrology and Department of ENT and Head and Neck Surgery. 2. The study particularly invites participation of all diagnosed Idiopathic Nephrotic Syndrome- on treatment with steroids and newly diagnosed cases of Nephrotic syndrome meeting the inclusion and exclusion criteria. Every patient’s parent or guardian will be given and informed consent form that should be duly signed. 3. Once consent is signed the patient will be sent to ENT OPD and the history will be taken and basic ear examination will be done using hearing evaluation proforma by the investigator. Microscopic examination of the ear will be done if needed. 4. the patient will be advised to undergo specific hearing tests: - Chirp ABR - TP-OAE 5. The patients will be divided into two groups- Newly diagnosed cases of Nephrotic syndrome and children with Nephrotic syndrome on multiple relapses on steroid treatment. 6. All reports will be collected in a proforma and data will be analyzed. |