Showing the Results of a Program of NHS in Cuiaba_ BrazilNCT01113450
Results of a Program of Newborn Hearing Screening (NHS) in Cuiaba-Brazil
An observational study of Showing the Results of a Program of NHS in Cuiaba_ Brazil, run by Centro de Diagnostico Auditivo de Cuiaba at 1 site in Brazil.
Trial summary
The study aims to demonstrate the indices of quality of a Newborn Hearing Screening (NHS). Read more about this study
- Who is it for?
- Ages 2 days to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Showing the Results of a Program of NHS in Cuiaba_ Brazil
- How many people
- 3,148 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Dec 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 2 days to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: There were two groups: 1. high risk for hearing loss 2. low risk for hearing loss
Who may be able to join
- middle ear conditions integrates
Who cannot join
- middle ear conditions inadequate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Results of a Program of Newborn Hearing Screening in Cuiaba-Brazil
The study aims to demonstrate the indices of quality of a Newborn Hearing Screening (NHS).
Read the detailed description
The data refer to infants underwent newborn hearing screening by evoked otoacoustic emissions by transient stimulation, using the analyzer EOA Biologic. Examinations archived in the computer's service were analyzed for the amount of infants who passed or failed the screening, as well as the correlations with the same age and gender.
- Keywords
- hearing, newborn, screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startJan 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Showing the Results of a Program of NHS in Cuiaba_ BrazilStudies 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
- Enrolment
- 3,148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Diagnostico Auditivo de Cuiaba
- Sponsor type
- University, hospital or other
- Investigators
- Priscila L Rodrigues, PHD student, Principal investigator, Centro de Diagnostico Auditivo de Cuiaba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113450
- Sponsor's protocol ID
- TAN Cuiaba
- Status last verified
- Dec 2009
- First submitted
- 29 Apr 2010
- Last updated
- 30 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of a Program of Newborn Hearing Screening in Cuiaba-Brazil
- ClinicalTrials.gov ID
- NCT01113450
- Acronym / sponsor ID
- TAN Cuiaba
- Keywords
- hearing, newborn, screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,148 participants (actual)
- Lead sponsor
- Centro de Diagnostico Auditivo de CuiabaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Apr 2010 (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.
The study aims to demonstrate the indices of quality of a Newborn Hearing Screening (NHS).
Detailed description
The data refer to infants underwent newborn hearing screening by evoked otoacoustic emissions by transient stimulation, using the analyzer EOA Biologic. Examinations archived in the computer's service were analyzed for the amount of infants who passed or failed the screening, as well as the correlations with the same age and gender.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 days to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- There were two groups: 1. high risk for hearing loss 2. low risk for hearing loss
Key inclusion criteria (1 listed)
- middle ear conditions integrates
Key exclusion criteria (1 listed)
- middle ear conditions inadequate
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 30 Apr 2010.
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.
Priscila L Rodrigues, PHD student principal investigator
Centro de Diagnostico Auditivo de Cuiaba
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 Showing the Results of a Program of NHS in Cuiaba_ Brazil, run by Centro de Diagnostico Auditivo de Cuiaba 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 1 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 30 Apr 2010. 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 30 Apr 2010.