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临床试验/NCT03410017
NCT03410017已完成不适用

Normative Data for the Functional Listening Index - Paediatric

Cochlear1 个研究点 分布在 1 个国家目标入组 536 人开始时间: 2017年11月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Cochlear
入组人数
536
试验地点
1
主要终点
Functional Listening Index

研究概览

简要总结

Single center, cross sectional observational research design to collect normative data on the acquisition of listening skills in normally-hearing children aged 0-6 years of age.

详细描述

The primary objective is the assessment of listening skill acquisition in normally-hearing children aged between 0 and 6 years with the Functional Listening Index - Paediatric (FLI-P). The FLI-P has been developed to address a substantial gap in the current tools available to measure the development of auditory skills in children. The FLI-P provides a measure of listening skills acquisition in children from birth to six years of age (0 - 72 months). The FLI-P will be administered by an investigator who has received appropriate training in its use or completed by parents/caregivers themselves. The FLI-P assessment will be conducted using an application running on a Personal Computer, tablet or online device. There are no specific medical or surgical procedures involved in this clinical investigation and the FLI-P is a non-interventional application.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
1 Day 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged between 0 and 6 years of age.
  • Pass on the Newborn Hearing Screen Status conducted during the New South Wales Statewide Infant Screening - Hearing (SWISH) Program.
  • No current parental or professional concern regarding hearing status.

排除标准

  • Pre-existing diagnosis of additional needs.
  • Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations of the study.
  • Unwillingness or inability of the subject to comply with all investigational requirements.

结局指标

主要结局

Functional Listening Index

时间窗: 1 day

The assessment of listening skill acquisition in normally-hearing children aged between 0 and 6 years with the Functional Listening Index - Paediatric (FLI-P).

次要结局

未报告次要终点

研究者

发起方
Cochlear
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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