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临床试验/CTRI/2023/03/051221
CTRI/2023/03/051221招募中Unknown

Feasibility of Oto-acoustic Emission assessment in identification of early and significant ototoxic hearing loss in pediatric cancer patients receiving Cisplatin based Chemotherapy

Tata Research Administrative Council0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
Unknown
状态
招募中
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • Following are the inclusion criteria for enrollment of the study participants.
  • 1.Pediatric cancer patients who are planned to receive Cisplatin based chemotherapy
  • 2.Pediatric cancer patients who must be within the age range of 3-17 years
  • 3.Pediatric cancer patients who must be able to provide consistent and reliable responses in conventional pure-tone audiometry
  • 4.Pediatric cancer patients who must present with normal OAE findings at all the test frequencies; i.e. I. For TEAOE, SNR equal to or greater than 6dBSPLand TEOAE level equal to or greater than 0 dBSPL at all the test frequencies with a minimum overall reproducibility rate of 80%; II. For DPOAE, SNR equal to or greater than 6 dBSPL and DPOAE level equal to or greater than 0 dBSPL with a minimum DP reliability rate of 98%based on DP tolerance level ±2 at all the test frequencies.

排除标准

  • Following ear-wise exclusion criteria at the time of enrollment will be taken for the study.
  • 1.Pediatric cancer patients with any middle ear pathology or previous ear surgery
  • 2.Pediatric cancer patients with any known pre-treatment hearing loss documented in baseline audiogram.
  • 3.Pediatric cancer patients with any known cognitive or psychological problems
  • 4.Pediatric cancer patients with any known ototoxic cancer treatment before.
  • 5.Pediatric cancer patients who are planned for cranial radiation therapy

研究者

发起方
Tata Research Administrative Council

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