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Completed

NCT Number: NCT03410017

FLI Normative Study

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.

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Key information

Age range

1 day–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The MARCS Institute Western Sydney University

Milperra, New South Wales, 2214, Australia

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Functional Listening Index

Other

Functional Listening Index questionnaire to assess acquisition of listening skills.

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Collaborators

  • The Hearing Cooperative Research Centre
  • The Shepherd Centre

Registry information

Official study title

Normative Data for the Functional Listening Index - Paediatric

Acronym: FLI-P

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 25, 2018
Registry last updated
Oct 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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