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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

Tracking Information
First Submitted Date October 1, 2017
First Posted Date January 25, 2018
Last Update Posted Date January 31, 2019
Actual Study Start Date November 1, 2017
Estimated Primary Completion Date October 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 23, 2018)
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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03410017 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title FLI Normative Study
Official Title Normative Data for the Functional Listening Index - Paediatric
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.
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Up to 700 normally-hearing children aged between 0 to 6 years of age.
Condition Hearing Loss
Intervention Other: Functional Listening Index
Functional Listening Index questionnaire to assess acquisition of listening skills.
Study Groups/Cohorts Normally-hearing
Children with normal hearing
Intervention: Other: Functional Listening Index
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: January 29, 2019)
536
Original Estimated Enrollment
 (submitted: January 23, 2018)
432
Estimated Study Completion Date October 6, 2019
Estimated Primary Completion Date October 6, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 6 Years   (Child)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia
Removed Location Countries  
 
Administrative Information
NCT Number NCT03410017
Other Study ID Numbers D1197624
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Cochlear
Study Sponsor Cochlear
Collaborators
  • The Hearing Cooperative Research Centre
  • The Shepherd Centre
Investigators
Principal Investigator: Aleisha Davis, MLSP The Hearing Cooperative Research Centre
PRS Account Cochlear
Verification Date January 2018