Normative Data for the Functional Listening Index - Paediatric
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
- 否
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
