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FLI Normative Study (FLI-P)

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ClinicalTrials.gov Identifier: NCT03410017
Recruitment Status : Active, not recruiting
First Posted : January 25, 2018
Last Update Posted : January 31, 2019
Sponsor:
Collaborators:
The Hearing Cooperative Research Centre
The Shepherd Centre
Information provided by (Responsible Party):
Cochlear

Brief Summary:
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.

Condition or disease Intervention/treatment
Hearing Loss Other: Functional Listening Index

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.

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Study Type : Observational
Actual Enrollment : 536 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Normative Data for the Functional Listening Index - Paediatric
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : October 6, 2019
Estimated Study Completion Date : October 6, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410017


Locations
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Australia, New South Wales
The MARCS Institute Western Sydney University
Milperra, New South Wales, Australia, 2214
Sponsors and Collaborators
Cochlear
The Hearing Cooperative Research Centre
The Shepherd Centre
Investigators
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Principal Investigator: Aleisha Davis, MLSP The Hearing Cooperative Research Centre

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Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT03410017     History of Changes
Other Study ID Numbers: D1197624
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cochlear:
Functional Listening Index

Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms