Cochlear FunctionNCT01325272
Interrelations Between Spontaneous Otoacoustic Emissions and Transient Evoked Emissions
An observational study of Cochlear Function, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 days to 5 monthsHealthy volunteers can take part
- Conditions the study is for
- Cochlear Function
- How many people
- Not given
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 days to 5 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children born in this institution
Who may be able to join
- born in this institution
- have presence of transient otoacoustic emission
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cochlear Function
- Keywords
- otoacoustic emissions in newborns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| preterm newborn | Not described | |
| term newborn | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startMar 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Investigators
- Daniela Polo Camargo da Silva, Mestre, Principal investigator, Faculdade de Medicina de Botucatu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325272
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-53
- Status last verified
- May 2011
- First submitted
- 28 Mar 2011
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interrelations Between Spontaneous Otoacoustic Emissions and Transient Evoked Emissions: Indication of Cochlear Damage in Newborn.
- ClinicalTrials.gov ID
- NCT01325272
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-53
- Conditions
- Cochlear Function
- Keywords
- otoacoustic emissions in newborns
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Study start
- Mar 2009
- Study completion
- Sep 2009
- First posted
- 29 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preterm newborn | – | – |
| term newborn | – | – |
Who may qualify
- Ages
- 4 days to 5 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children born in this institution
Key inclusion criteria (2 listed)
- born in this institution
- have presence of transient otoacoustic emission
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2011.
Related trials for Cochlear Function
Recruiting
Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS
Deafness
Not yet recruiting
Optimization and Validation of Electric Acoustic Stimulation (EAS) Mapping as a Function of Residual Hearing After CI-Implantation
Fitting Methods by EAS Patients
Enrolling by invitation
Auditory-Cognitive Training to Optimize Outcomes for Older CI Users
Hearing Loss, Deafness
RecruitingObservational study
Cochlear Implant Recipients: Comprehensive Longitudinal Evaluation
Hearing Loss, Hearing Loss, Sensorineural
Recruiting
fNIRS in Pediatric Hearing Aids
Hearing Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela Polo Camargo da Silva, Mestre principal investigator
Faculdade de Medicina de Botucatu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cochlear Function, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2011.