FLI Normative Study (FLI-P)

October 27, 2021 updated by: Cochlear

Normative Data for the Functional Listening Index - Paediatric

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

536

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Milperra, New South Wales, Australia, 2214
        • The MARCS Institute Western Sydney University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 6 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Up to 700 normally-hearing children aged between 0 to 6 years of age.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normally-hearing
Children with normal hearing
Other: Functional Listening Index
Functional Listening Index questionnaire to assess acquisition of listening skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Listening Index
Time Frame: 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).
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear

Collaborators

The Hearing Cooperative Research Centre
The Shepherd Centre

Investigators

  • Principal Investigator: Aleisha Davis, MLSP, The Hearing Cooperative Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2017

Primary Completion (Actual)

October 8, 2018

Study Completion (Actual)

December 17, 2018

Study Registration Dates

First Submitted

October 1, 2017

First Submitted That Met QC Criteria

January 23, 2018

First Posted (Actual)

January 25, 2018

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLTD5703

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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