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FLI Normative Study

NCT ID: NCT03410017

Last Updated: 2021-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

536 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-03

Study Completion Date

2018-12-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hearing Loss

Keywords

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Functional Listening Index

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Normally-hearing

Children with normal hearing

Functional Listening Index

Intervention Type OTHER

Functional Listening Index questionnaire to assess acquisition of listening skills.

Interventions

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Functional Listening Index

Functional Listening Index questionnaire to assess acquisition of listening skills.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hearing Cooperative Research Centre

OTHER

Sponsor Role collaborator

The Shepherd Centre

UNKNOWN

Sponsor Role collaborator

Cochlear

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aleisha Davis, MLSP

Role: PRINCIPAL_INVESTIGATOR

The Hearing Cooperative Research Centre

Locations

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The MARCS Institute Western Sydney University

Milperra, New South Wales, Australia

Site Status

Countries

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Australia

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CLTD5703

Identifier Type: -

Identifier Source: org_study_id