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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03410017
Ethics application status
Date submitted
1/10/2017
Date registered
25/01/2018
Date last updated
29/10/2021

Titles & IDs
Public title
FLI Normative Study
Scientific title
Normative Data for the Functional Listening Index - Paediatric
Secondary ID [1] 0 0
CLTD5703
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
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
1 Day
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/12/2018
Sample size
Target
Accrual to date
Final
536
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/study/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/study/NCT03410017