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| Name | Class |
|---|---|
| The Hearing Cooperative Research Centre | OTHER |
| The Shepherd Centre | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normally-hearing | Children with normal hearing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional Listening Index | Other | Functional Listening Index questionnaire to assess acquisition of listening skills. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional Listening Index | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Up to 700 normally-hearing children aged between 0 to 6 years of age.
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| Name | Affiliation | Role |
|---|---|---|
| Aleisha Davis, MLSP | The Hearing Cooperative Research Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The MARCS Institute Western Sydney University | Milperra | New South Wales | 2214 | Australia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 7, 2019 | Oct 25, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |