Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000051347
Ethics application status
Approved
Date submitted
23/01/2008
Date registered
29/01/2008
Date last updated
2/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative study of audiometrics tests on metallurgical workers exposed to noise only as well as noise associated to the chemical products handling.
Scientific title
Comparative study of audiometrics tests on metallurgical workers exposed to noise only as well as noise associated to the chemical products handling.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hearing loss 2750 0
Condition category
Condition code
Ear 2876 2876 0 0
Deafness

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
to perform a comparative study, through audiometrics tests, of workers exposed to noise only as well as noise associated to the chemical products. 71 metallurgists exposed to noise and chemical products (group II) for a period that varies from 3 to 20 years.The workers were exposed to noise from heavy machinery and chemicals such as styrene, acetone, resin, cobalt, among others.
Intervention code [1] 2491 0
Not applicable
Comparator / control treatment
81 metallurgists exposed to noise(group I) for a period that varies from 3 to 20 years.The range of noise dBNA wobbled between 80.5 and 99.5 dBNA, and the exposure time was 8 hours a day.
Control group
Historical

Outcomes
Primary outcome [1] 3760 0
occupational hearing loss in the group I through audiometric tests
Timepoint [1] 3760 0
After an average of 7.6 years of exposure
Primary outcome [2] 3761 0
occupational hearing loss in the group II through audiometric tests
Timepoint [2] 3761 0
After an average of 6.1 years of exposure
Secondary outcome [1] 6354 0
right ear occupational hearing loss in the group II through audiometric tests
Timepoint [1] 6354 0
In 15.5% of the metallurgical Workers

Eligibility
Key inclusion criteria
occupational hearing loss
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
conductive hearing loss

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
155
Accrual to date
Final
Recruitment outside Australia
Country [1] 751 0
Brazil
State/province [1] 751 0
rio de janeiro

Funding & Sponsors
Funding source category [1] 3004 0
Self funded/Unfunded
Name [1] 3004 0
carla tomaz botelho
Country [1] 3004 0
Brazil
Primary sponsor type
Individual
Name
carla tomaz botelho
Address
Rua Tomé de Souza - 67 Cruzeiro - Belo Horizonte. Minas Gerais. 30140-130
Country
Brazil
Secondary sponsor category [1] 2708 0
Individual
Name [1] 2708 0
Anna Paulla Maia Lopes Paz
Address [1] 2708 0
Maria Maia, 307 / 202
CEP: 21360 170 - Rio de Janeiro - RJ
Country [1] 2708 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4962 0
Centro de Especializacao em Fonoaudiologia Clinica CEFAC
Ethics committee address [1] 4962 0
Rua Cayowa, 664 05018-000 Sao Paulo - SP.
Ethics committee country [1] 4962 0
Brazil
Date submitted for ethics approval [1] 4962 0
Approval date [1] 4962 0
05/07/2006
Ethics approval number [1] 4962 0
127/06

Summary
Brief summary
to perform a comparative study, through audiometrics tests, of workers exposed to noise only as well as noise associated to the chemical products. The hypothesis is that the Group II will have higher prevalence of occupational hearing loss when compared to group I.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28321 0
Address 28321 0
Country 28321 0
Phone 28321 0
Fax 28321 0
Email 28321 0
Contact person for public queries
Name 11478 0
Carla Tomaz Botelho
Address 11478 0
Rua Tomé de Souza - 67 Cruzeiro - Belo Horizonte. Minas Gerais
Country 11478 0
Brazil
Phone 11478 0
(31)3221-9656
Fax 11478 0
Email 11478 0
[email protected]
Contact person for scientific queries
Name 2406 0
Carla Tomaz Botelho
Address 2406 0
Rua Tomé de Souza - 67 Cruzeiro - Belo Horizonte. Minas Gerais
Country 2406 0
Brazil
Phone 2406 0
(31)3221-9656
Fax 2406 0
Email 2406 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.