TO STUDY ASSOCIATION BETWEEN CHILDREN WITH NEPHROTIC SYNDROME AND HEARING LOSS: A CROSS-SECTIONAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Evaluation of hearing loss in children diagnosed with Nephrotic syndrome using Chirp ABR (Chirp- Auditory brainstem response) and TP-OAE (Transitory evoked otoacoustic emission.
研究概览
简要总结
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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.
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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.
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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.
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the patient will be advised to undergo specific hearing tests:
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Chirp ABR
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TP-OAE
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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.
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All reports will be collected in a proforma and data will be analyzed.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed cases of Idiopathic Nephrotic Syndrome
- •Age 2 to 12 years.
排除标准
- •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
- •children with cognitive impairment, language barrier
- •Refusal or Inability to Provide Informed Consent.
结局指标
主要结局
Evaluation of hearing loss in children diagnosed with Nephrotic syndrome using Chirp ABR (Chirp- Auditory brainstem response) and TP-OAE (Transitory evoked otoacoustic emission.
时间窗: 24/02/2025 TO 01/03/2026
次要结局
- 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.)
研究者
DR SHREYANSHI GUPTA
KASTURBA MEDICAL COLLEGE, MANIPAL