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Trial registered on ANZCTR


Registration number
ACTRN12615000170527
Ethics application status
Approved
Date submitted
10/02/2015
Date registered
20/02/2015
Date last updated
10/03/2022
Date data sharing statement initially provided
14/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Speech Discrimination and Early Acquisition of Language in Infants with Hearing Loss
Scientific title
Investigating the relationship between early auditory speech discrimination and later language skills in infants with hearing loss
Secondary ID [1] 286027 0
None
Universal Trial Number (UTN)
U1111-1166-3846
Trial acronym
Infant Discrimination and Early Acquisition of Language (IDEAL) Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss 294000 0
Condition category
Condition code
Ear 294296 294296 0 0
Deafness
Public Health 294531 294531 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Children with bilateral hearing loss, between ages 3 to 12 months in NSW and VIC, will be recruited through the national hearing service provider, Australian Hearing. Children will complete: 1) objective (cortical auditory evoked potentials in response to sound changes) assessment of speech discrimination at 6-8 weeks post hearing-aid fitting, and 2) objective and behavioural (head/eye movements in response to sound changes) assessments of speech discrimination at 7-12 months of age. They will return at chronological age of 3 years for repeat assessments of speech discrimination and additionally tests of their speech and language ability. In addition, data will be collected on the child's auditory behaviour in everyday life and family demographics from parent questionnaires. We also include a normative, comparison group of typically hearing infants who will complete the same assessments as the children with hearing loss. The findings will lead to novel clinical tools for assessing auditory discrimination in infants, early referral for cochlear implantation if necessary, and new evidence-based clinical guidelines for best practice management of children with hearing loss.
Intervention code [1] 291010 0
Not applicable
Comparator / control treatment
This is an observational study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294100 0
Objective auditory discrimination - recording of cortical responses (i.e. auditory evoked potentials) to speech sound contrasts.
Timepoint [1] 294100 0
Evaluations will be made at three timepoints: within 3 months of initial fitting of hearing aids; and again at chronological ages of 12 months and 3 years.
Primary outcome [2] 294101 0
Behavioural auditory discrimination - recording of correct behavioural responses (i.e. head/eye movements) to changes in speech sound contrasts.
Timepoint [2] 294101 0
Evaluations will be made at two timepoints: 3 months after a child is fitted with hearing aids; and then again at chronological age of 3 years.
Primary outcome [3] 294102 0
Speech and language ability - standardised tests of expressive and receptive language that involve direct administration and parent reports will be used.
Timepoint [3] 294102 0
Evaluations of speech and language ability will be made at chronological age of 3 years.
Secondary outcome [1] 312509 0
Written parent questionnaires - The Parent’s evaluation of Aural/oral performance of children (PEACH) and a questionnaire on demographic details relating to parental education level, language and communication mode at home, and the child’s age at enrolment in early education (if applicable).
Timepoint [1] 312509 0
Evaluations will be made at two timepoints: 3 months after a child is fitted with hearing aids; and then again at chronological age of 3 years.

Eligibility
Key inclusion criteria
Participants will be infants: (1) below 12 months of age, (2) detected with bilateral hearing loss, and (3) to be fitted with hearing aids or been fitted with hearing aids in the previous 3 months.
Minimum age
1 Months
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria are (1) parent indication that the family does not wish to be contacted for research purposes, (2) presence of any diagnosed disabilities in addition to hearing loss, (3) parents who are not willing to travel to the Australian Hearing Hub (in NSW) or Melbourne University (in VIC) for testing, and (4) children who use a cochlear implant.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Factor analysis will be used to combine the outcomes scores at 3 years into one or more factors. Standard multiple linear regression analysis will be used to examine the relationship between language outcome scores and potential predictor variables (including objective speech-discrimination, behavioural speech-discrimination, degree of hearing loss, age of fitting, communication mode, maternal education, socio-economic advantage, gender, other disabilities, and presence of auditory neuropathy spectrum disorder). Their relation to each other will be assessed with correlation analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/07/2015
Actual
10/08/2015
Date of last participant enrolment
Anticipated
Actual
23/05/2018
Date of last data collection
Anticipated
30/09/2021
Actual
3/02/2021
Sample size
Target
150
Accrual to date
Final
146
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 290621 0
Government body
Name [1] 290621 0
NHMRC
Country [1] 290621 0
Australia
Primary sponsor type
Government body
Name
National Acoustic Laboratories, Australian Hearing
Address
National Acoustic Laboratories,
Australian Hearing Hub
16 University Ave
Macquarie University
NSW 2109
Country
Australia
Secondary sponsor category [1] 289306 0
Other Collaborative groups
Name [1] 289306 0
The HEARing Cooperative Research Centre Limited
Address [1] 289306 0
550 Swanston Street
Audiology, Hearing and Speech Sciences
The University of Melbourne
Victoria 3010
Country [1] 289306 0
Australia
Other collaborator category [1] 278300 0
University
Name [1] 278300 0
Macquarie University
Address [1] 278300 0
Macquarie University NSW 2109 Australia
Country [1] 278300 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292257 0
Australian Hearing Human Research Ethics Committee (EC00109)
Ethics committee address [1] 292257 0
National Acoustic Laboratories
Level 5, 16 University Avenue
Australian Hearing Hub
Macquarie University
NSW 2109
Ethics committee country [1] 292257 0
Australia
Date submitted for ethics approval [1] 292257 0
19/01/2015
Approval date [1] 292257 0
22/01/2015
Ethics approval number [1] 292257 0
AHHREC2015-1

Summary
Brief summary
Now that newborn hearing checks are available, hearing loss is often picked up soon after birth and hearing aids are fitted shortly after. There are standard procedures for checking that the hearing aids make sounds audible to a child, but no one knows how effective the hearing aids are for supporting discrimination between sounds because there are no clinical tools to do so. Further, no one knows whether this early discrimination ability may relate to later language development of children with hearing loss.

The IDEAL study aims to 1) develop new clinical tools for assessing whether an infant with hearing loss can hear the differences between sounds after they are fitted with hearing aids; and 2) determine the relationship between early auditory discrimination and spoken language skills at 3 years of age for children with hearing loss. The findings will provide the much-needed evidence to guide best-practice management of children with hearing loss.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54310 0
Prof Teresa Ching
Address 54310 0
NextSense Institute, aff with Macquarie University, 361-365 North Rocks Road, North Rocks, NSW 2151, AU
Country 54310 0
Australia
Phone 54310 0
+612 9412 6832
Fax 54310 0
+612 9412 6769
Email 54310 0
[email protected]
Contact person for public queries
Name 54311 0
Vicky Zhang
Address 54311 0
National Acoustic Laboratories
Australian Hearing Hub
Level 5, 16 University Avenue,
Macquarie University,
Ryde, NSW 2109
Country 54311 0
Australia
Phone 54311 0
+612 9412 6735
Fax 54311 0
+612 9412 6769
Email 54311 0
[email protected]
Contact person for scientific queries
Name 54312 0
Teresa Ching
Address 54312 0
NextSense Institute, aff with Macquarie University, 361-365 North Rocks Road, North Rocks, NSW 2151, AU
Country 54312 0
Australia
Phone 54312 0
+612 9412 6832
Fax 54312 0
+612 9412 6769
Email 54312 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
current ethics approval has not provided for data sharing.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.