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Clinical Trials/CTRI/2025/02/080876
CTRI/2025/02/080876
Not yet recruiting
Not Applicable

TO STUDY ASSOCIATION BETWEEN CHILDREN WITH NEPHROTIC SYNDROME AND HEARING LOSS: A CROSS-SECTIONAL STUDY

MAHE KASTURBA HOSPITAL1 site in 1 country88 target enrollmentStarted: February 24, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
MAHE KASTURBA HOSPITAL
Enrollment
88
Locations
1
Primary Endpoint
Evaluation of hearing loss in children diagnosed with Nephrotic syndrome using Chirp ABR (Chirp- Auditory brainstem response) and TP-OAE (Transitory evoked otoacoustic emission.

Overview

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

  1. 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.

  2. All reports will be collected in a proforma and data will be analyzed.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
2.00 Year(s) to 12.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Diagnosed cases of Idiopathic Nephrotic Syndrome
  • Age 2 to 12 years.

Exclusion Criteria

  • Age less than 2 year and more than 12 year
  • Children with congenital hearing loss
  • Children of Nephrotic syndrome associated with hearing loss secondary to ASOM/CSOM and ear trauma or surgical interventions related to hearing
  • Children with previously known hearing impairment
  • Children with any other medical or surgical illness causing hearing impairment
  • Patients with known comorbidities
  • Children with history of Acute febrile illness (Meningitis, Encephalitis, etc)
  • Children with history of ear infection with history of Ototoxic drug intake
  • nephrotic patients with renal insufficiency
  • children with known neurological disorders that may affect hearing

Outcomes

Primary Outcomes

Evaluation of hearing loss in children diagnosed with Nephrotic syndrome using Chirp ABR (Chirp- Auditory brainstem response) and TP-OAE (Transitory evoked otoacoustic emission.

Time Frame: 24/02/2025 TO 01/03/2026

Secondary Outcomes

  • 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.)

Investigators

Sponsor
MAHE KASTURBA HOSPITAL
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

DR SHREYANSHI GUPTA

KASTURBA MEDICAL COLLEGE, MANIPAL

Study Sites (1)

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