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Trial registered on ANZCTR


Registration number
ACTRN12611000429954
Ethics application status
Approved
Date submitted
20/04/2011
Date registered
27/04/2011
Date last updated
1/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Longitudinal outcomes of hearing-impaired children: early versus later identification
Scientific title
Longitudinal outcomes of hearing-impaired children: early versus later identification
Secondary ID [1] 260045 0
Nil
Universal Trial Number (UTN)
U1111-1118-8875
Trial acronym
LOCHI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing loss 265707 0
Condition category
Condition code
Ear 265846 265846 0 0
Deafness

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Permanent childhood hearing loss impacts negatively on the speech, language, communicative, educational, and social developmental outcomes of children. This population-based study compares outcomes of children whose hearing loss was identified soon after birth to those of children identified later in a prospective manner. Children in NSW, Victoria and Queensland who presented for hearing services below 3 years of age at the national hearing service provider, Australian Hearing, were invited to participate in this study. About half of them had access to newborn hearing screening and the remaining did not. After enrollment, their speech, language and functional outcomes are being measured at fixed intervals over their first 10 years of life, and changes in their hearing status are monitored. These outcomes data will be related to a range of family, child and intervention characteristics. The effect of different factors, including age of intervention, on different outcomes will be quantified. The results will be used to guide best-practice intervention and monitoring of children following diagnosis.
Intervention code [1] 264464 0
Not applicable
Comparator / control treatment
This is an observational study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266607 0
Language development - standardised tests of expressive and receptive language that involve direct administration and parent reports will be used.
Timepoint [1] 266607 0
The evaluations will be made at 6 months and 12 months after a child first received hearing aids or cochlear implants; and then again at chronological ages of 3 years, 5 years, and 9 years.
Primary outcome [2] 266608 0
Speech development - tests of speech production and speech perception will be used.
Timepoint [2] 266608 0
The evaluations will be made at chronological ages of 3 years, 5 years and 9 years.
Primary outcome [3] 266609 0
Psychosocial development and quality of life - standardized tests will be used.
Timepoint [3] 266609 0
The evaluations will be made at 6 months and 12 months after a child first received hearing aids or cochlear implants; and then again at chronological ages of 3 years, 5 years, and 9 years.
Secondary outcome [1] 276088 0
Hearing status - changes over time.
Timepoint [1] 276088 0
The assessment (service provision data to be collected from service providers) will be made at 3 years, 5 years and 9 years of age.
Secondary outcome [2] 276089 0
Intervention - changes in self-sought interventions over time.
Timepoint [2] 276089 0
The assessment (service provision data to be collected from service providers) will be made at 3 years, 5 years and 9 years.
Secondary outcome [3] 323786 0
Changes in hearing device setting
Timepoint [3] 323786 0
The parameter settings of hearing devices to be collected from service providers will be made when participants are evaluated at age 3 years, 5 years and 9 years.

Eligibility
Key inclusion criteria
Children in New South Wales, Victoria and Queensland who were born between 2002 and 2007, and who presented for hearing services at specialist paediatric hearing centres of Australian Hearing before 3 years of age.
Eligible participants will be deemed healthy.
Minimum age
No limit
Maximum age
3 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children who were over 3 years of age when they first received services from Australian Hearing.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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,QLD,VIC
Recruitment postcode(s) [1] 3938 0
4001
Recruitment postcode(s) [2] 3939 0
4122
Recruitment postcode(s) [3] 3940 0
2289
Recruitment postcode(s) [4] 3941 0
2067
Recruitment postcode(s) [5] 3942 0
2170
Recruitment postcode(s) [6] 3943 0
2150
Recruitment postcode(s) [7] 3944 0
2000
Recruitment postcode(s) [8] 3945 0
3128
Recruitment postcode(s) [9] 3946 0
3175

Funding & Sponsors
Funding source category [1] 264936 0
Government body
Name [1] 264936 0
National Institutes on Deafness and Other Communication Disorders
Address [1] 264936 0
National Institutes of Health
6701 Rockledge Drive
Room 1040 - Msc 7710
Bethesda, MD 20817
USA
Country [1] 264936 0
United States of America
Funding source category [2] 264937 0
Government body
Name [2] 264937 0
National Acoustic Laboratories, Australian Hearing
Address [2] 264937 0
NAL, Australian Hearing
Australian Hearing Hub building
Level 5 / 16 University Avenue
Macquarie University NSW 2109
Country [2] 264937 0
Australia
Funding source category [3] 264938 0
Other Collaborative groups
Name [3] 264938 0
The HEARing Cooperative Research Centre Limited
Address [3] 264938 0
550 Swanston Street
Audiology, Hearing and Speech Sciences
The University of Melbourne
Victoria 3010
Country [3] 264938 0
Australia
Primary sponsor type
Government body
Name
National Acoustic Laboratories, Australian Hearing
Address
Australian Hearing Hub Level 5
16 University Ave
Macquarie University
NSW 2109
Country
Australia
Secondary sponsor category [1] 264036 0
Other Collaborative groups
Name [1] 264036 0
The HEARing Cooperative Research Centre Limited
Address [1] 264036 0
550 Swanston Street
Audiology, Hearing and Speech Sciences
The University of Melbourne
Victoria 3010
Country [1] 264036 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266901 0
Australian Hearing Human Research Ethics Committee (EC00109)
Ethics committee address [1] 266901 0
Australian Hearing
Australian Hearing Hub building
Level 5 / 16 University Avenue
Macquarie University NSW 2109
Ethics committee country [1] 266901 0
Australia
Date submitted for ethics approval [1] 266901 0
Approval date [1] 266901 0
10/01/2005
Ethics approval number [1] 266901 0
AHHREC2004-1

Summary
Brief summary
This population-based study has two broad aims. The first is to derive speech, language, psycho-social and functional norms for children aided with hearing aids and/or cochlear implants. The second is to determine the effects of multiple factors, including age of intervention, on developmental outcomes of children with hearing loss. It is hypothesized that:
1. Compared to children who received later intervention, children who received early intervention will score better on measures of language, speech, functional performance and quality of life.
2. Compared to children who received later intervention, children who received early intervention will develop at a rate closer to that of normal hearing children over the first 10 years of life.
Trial website
www.outcomes.nal.gov.au
Trial related presentations / publications
Ching TYC, Crowe K, Martin V, Day J, Mahler N, Youn S, Street L, Cook Cassandra, Orsini J (2010). Language development and everyday functioning of children with hearing loss assessed at 3 years of age. International Journal of Speech-Language Pathology 12(2):124-131.
Public notes

Contacts
Principal investigator
Name 32523 0
Dr Teresa Ching
Address 32523 0
National Acoustic Laboratories,
Australian Hearing
Australian Hearing Hub building
Level 5 / 16 University Avenue
Macquarie University NSW 2109
Country 32523 0
Australia
Phone 32523 0
+612 9412 6832
Fax 32523 0
Email 32523 0
Teresa.Ching@nal.gov.au
Contact person for public queries
Name 15770 0
Ms Laura Button
Address 15770 0
National Acoustic Laboratories,
c/-Australian Hearing
Office 014, Level 2 Offices
Centro Box Hill North
17 Market St,
Box Hill, VIC 3128
Country 15770 0
Australia
Phone 15770 0
+613 9236 1020
Fax 15770 0
+612 9412 6769
Email 15770 0
Laura.Button@hearing.com.au
Contact person for scientific queries
Name 6698 0
Dr Teresa Ching
Address 6698 0
Australian Hearing
Australian Hearing Hub building
Level 5 / 16 University Avenue
Macquarie University NSW 2109
Country 6698 0
Australia
Phone 6698 0
+61 2 9412 6832
Fax 6698 0
+612 9412 6769
Email 6698 0
Teresa.Ching@nal.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary