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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03410017




Registration number
NCT03410017
Ethics application status
Date submitted
1/10/2017
Date registered
25/01/2018
Date last updated
31/01/2019

Titles & IDs
Public title
FLI Normative Study
Scientific title
Normative Data for the Functional Listening Index - Paediatric
Secondary ID [1] 0 0
D1197624
Universal Trial Number (UTN)
Trial acronym
FLI-P
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Functional Listening Index

Normally-hearing - Children with normal hearing


Other interventions: Functional Listening Index
Functional Listening Index questionnaire to assess acquisition of listening skills.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
1 day

Eligibility
Key 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.
Minimum age
No limit
Maximum age
6 Years
Gender
Both males and females
Can healthy volunteers participate?
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The MARCS Institute Western Sydney University - Milperra
Recruitment postcode(s) [1] 0 0
2214 - Milperra

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cochlear
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Hearing Cooperative Research Centre
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The Shepherd Centre
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03410017
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Aleisha Davis, MLSP
Address 0 0
The Hearing Cooperative Research Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03410017