CTRI/2023/03/051221
Recruiting
未知
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 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Tata Research Administrative Council
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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