- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01325272
Interrelations Between Spontaneous Otoacoustic Emissions and Transient Evoked Emissions
May 31, 2011 updated by: UPECLIN HC FM Botucatu Unesp
Interrelations Between Spontaneous Otoacoustic Emissions and Transient Evoked Emissions: Indication of Cochlear Damage in Newborn.
To verify the occurrence of Spontaneous Otoacoustic Emissions (SOAE) in neonates at term and preterm infants who had transient otoacoustic emissions and verify if the presence of response is related to gestational age, gender or risk factors for hearing loss.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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SP
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Botucatu, SP, Brazil, 18603970
- Faculdade de Medicina de Botucatu
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 days to 5 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Children born in this institution
Description
Inclusion Criteria:
- born in this institution
- have presence of transient otoacoustic emission
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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preterm newborn
|
term newborn
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniela Polo Camargo da Silva, Mestre, Faculdade de Medicina de Botucatu
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Study Completion
September 1, 2009
Study Registration Dates
First Submitted
March 28, 2011
First Submitted That Met QC Criteria
March 28, 2011
First Posted (Estimate)
March 29, 2011
Study Record Updates
Last Update Posted (Estimate)
June 1, 2011
Last Update Submitted That Met QC Criteria
May 31, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- upeclin/HC/FMB-Unesp-53
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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