NCT03410017

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
536

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

November 3, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2018

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

Enrollment Period

11 months

First QC Date

October 1, 2017

Last Update Submit

October 27, 2021

Conditions

Hearing Loss

Keywords

Functional Listening Index

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Normally-hearing

Children with normal hearing

Other: Functional Listening Index

Interventions

Functional Listening IndexOTHER

Functional Listening Index questionnaire to assess acquisition of listening skills.

Normally-hearing

Eligibility Criteria

Age1 Day - 6 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Up to 700 normally-hearing children aged between 0 to 6 years of age.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The MARCS Institute Western Sydney University

Milperra, New South Wales, 2214, Australia

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aleisha Davis, MLSP

    The Hearing Cooperative Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2017

First Posted

January 25, 2018

Study Start

November 3, 2017

Primary Completion

October 8, 2018

Study Completion

December 17, 2018

Last Updated

October 29, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)