Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000321044
Ethics application status
Approved
Date submitted
17/04/2010
Date registered
21/04/2010
Date last updated
21/04/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Benefit assessment of hearing aid use in children and teenagers
Scientific title
Benefit assessment of sound amplification use in hearing impaired children and teenagers: An observational, cross-sectional, cohort study
Secondary ID [1] 251626 0
'nil'
Universal Trial Number (UTN)
U1111-1114-7091
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hearing loss 257201 0
Condition category
Condition code
Ear 257348 257348 0 0
Deafness

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The Infant Toddler Meaningful Auditory Integration Scale (IT-MAIS), to children under four years-old was applied; to children between 04 and 07 years old the Meaningful Auditory Integration Scale (MAIS) was applied and for the individuals between 08 and 14 years old the benefit questionnaire assessing in children and teenagers proposed by Boscolo et al (2006).
The application was made in a single session of 30 minutes. The total study duration was 4 months old.
Intervention code [1] 256331 0
Not applicable
Comparator / control treatment
'not applicable'
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258263 0
The Infant Toddler Meaningful Auditory Integration Scale (IT-MAIS), was appliedto children under four years-old; to children between 04 and 07 years old the Meaningful Auditory Integration Scale (MAIS) was applied and for the individuals between 08 and 14 years old the benefit questionnaire assessing in children and teenagers proposed by Boscolo et al (2006).
Timepoint [1] 258263 0
Patients were recalled for assessment after completing at least three months of the effective use of hearing aids. The calls were made to assess from the month of April 2009 until August 2009.
Secondary outcome [1] 263919 0
'nil'
Timepoint [1] 263919 0
'nil'

Eligibility
Key inclusion criteria
Participated in this study, hearing impaired individuals which were fitted with hearing aids in Laboratory of Hearing of of Federal University of Santa Maria (FUSM) through the health care program for hearing of this institution. This program is in effect since 2005 and serves the municipalities in the average complexity of the macro-Midwest region of Rio Grande do Sul.
Were evaluated only individuals whose parents or guardians have agreed to the procedures necessary to implement the search and signed a consent form after receiving clarification on the purpose and methodology of the proposed study.
To be part of the research, the established inclusion criteria were: age between 03 and 14 years and a minimum of three months of use of amplification, because clinical experience has shown that this is a reasonable time to adjust to hearing aids, and able to verify the actual results of the intervention, since the benefits from the use of amplification do not emerge immediately (Weinstein, 1996).
Minimum age
3 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
nil

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
63
Accrual to date
Final
Recruitment outside Australia
Country [1] 2593 0
Brazil
State/province [1] 2593 0
Santa MAria

Funding & Sponsors
Funding source category [1] 256835 0
University
Name [1] 256835 0
Universidade Federal de Santa Maria
Country [1] 256835 0
Brazil
Primary sponsor type
Individual
Name
Nilvia Soares Aurelio
Address
Venancio Aires, 454-a, Passo Dareia, Santa Maria-RS, 97010-001
Country
Brazil
Secondary sponsor category [1] 256110 0
None
Name [1] 256110 0
Address [1] 256110 0
Country [1] 256110 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258852 0
Committee of Ethics in Research (CER) of Federal University of Santa Maria (FUSM)
Ethics committee address [1] 258852 0
Avenida Roraima, 1000, Cidade Universitaria, Camobi, Santa Maria - RS
97105-900
Ethics committee country [1] 258852 0
Brazil
Date submitted for ethics approval [1] 258852 0
05/12/2006
Approval date [1] 258852 0
27/11/2008
Ethics approval number [1] 258852 0
Protocol 23081.0.016862/2006-09.

Summary
Brief summary
Assess the benefit granted by the sound amplification use iin children and teenagers assisted by the program of health care hearing of Federal University of Santa Maria (FUSM).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31069 0
Address 31069 0
Country 31069 0
Phone 31069 0
Fax 31069 0
Email 31069 0
Contact person for public queries
Name 14316 0
Nilvia Soares Aurelio
Address 14316 0
Venancio Aires, 454-A, Passo Dareia, Santa Maria -RS, 97010-001
Country 14316 0
Brazil
Phone 14316 0
(55)32269238
Fax 14316 0
Email 14316 0
[email protected]
Contact person for scientific queries
Name 5244 0
Nilvia Soares Aurelio
Address 5244 0
Venancio Aires, 454-A, Passo Dareia, Santa Maria -RS, 97010-001
Country 5244 0
Brazil
Phone 5244 0
(55)32269238
Fax 5244 0
Email 5244 0
[email protected]

No information has been provided regarding IPD availability


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.