DeafnessNHSNCT00753194
False Positive Results in Newborn Hearing Screening
An observational study of Deafness, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to investigate the rate of false-positive results in Newborn Universal Hearing Screening Programs and it´s possible causes. Read more about this study
- Who is it for?
- Ages 6 to 48 hoursHealthy volunteers can take part
- Conditions the study is for
- Deafness
- How many people
- 1,110 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2005to Jan 2007
- 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 6 to 48 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Newborns
Who may be able to join
- Healthy newborns
Who cannot join
- Risk factors for hearing loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: False-Positive Results in Newborn Hearing Screening: Possible Causes
The purpose of this study is to investigate the rate of false-positive results in Newborn Universal Hearing Screening Programs and it´s possible causes.
Read the detailed description
False-positive results in Newborn Hearing Screening(NHS) leads to unnecessary parents anxiety and increase the cost of the procedure before hospital discharge. Getting to know the possible causes will lead to solutions to decrease the number of normal hearing babies that fail NHS with Otoacoustic Emissions.
- Conditions
- Deafness
- Keywords
- hearing, newborn, otoacoustic emissions
- Medical subject headings
- Deafness
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 |
|---|---|---|
| 1 | Newborns that show a "Pass" On the newborn hearing screening program before hospital discharge | |
| 2 | Newborns that show a "fail" and will be retested in 15 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Otoacoustic Emissions
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study startMar 2005
- Primary completionMar 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeafnessStudies 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Marisa Frasson, Doctor, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753194
- Sponsor's protocol ID
- 2612
- Other IDs
- 26129
- Acronym
- NHS
- Status last verified
- Sep 2008
- First submitted
- 15 Sep 2008
- Last updated
- 16 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Grill E, Uus K, Hessel F, Davies L, Taylor RS, Wasem J, Bamford J. Neonatal hearing screening: modelling cost and effectiveness of hospital- and community-based screening. BMC Health Serv Res. 2006 Feb 23;6:14. doi: 10.1186/1472-6963-6-14.
PubMed 16504089
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- False-Positive Results in Newborn Hearing Screening: Possible Causes
- ClinicalTrials.gov ID
- NCT00753194
- Acronym / sponsor ID
- NHS / 2612
- Conditions
- Deafness
- Keywords
- hearing, newborn, otoacoustic emissions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,110 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 16 Sep 2008 (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 purpose of this study is to investigate the rate of false-positive results in Newborn Universal Hearing Screening Programs and it´s possible causes.
Detailed description
False-positive results in Newborn Hearing Screening(NHS) leads to unnecessary parents anxiety and increase the cost of the procedure before hospital discharge. Getting to know the possible causes will lead to solutions to decrease the number of normal hearing babies that fail NHS with Otoacoustic Emissions.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Newborns that show a "Pass" On the newborn hearing screening program before hospital discharge |
| 2 | – | –Newborns that show a "fail" and will be retested in 15 days. |
Who may qualify
- Ages
- 6 to 48 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Newborns
Key inclusion criteria (1 listed)
- Healthy newborns
Key exclusion criteria (1 listed)
- Risk factors for hearing loss
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
Otoacoustic Emissions
Time frame: At birth
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 16 Sep 2008.
- Results publication: PubMed 16504089Grill E, Uus K, Hessel F, Davies L, Taylor RS, Wasem J, Bamford J. Neonatal hearing screening: modelling cost and effectiveness of hospital- and community-based screening. BMC Health Serv Res. 2006 Feb 23;6:14. doi: 10.1186/1472-6963-6-14.
Related trials for Deafness
Recruiting
Barriers and Facilitators to OTC Hearing Aids Success
Hearing Loss, Sensorineural, Presbycusis
Not yet recruitingObservational study
New Hearing Aid Users and Their Social Participation
Hearing Loss, Hearing Aids
Recruiting
ENACT Program on Auditory Perception and Function, Cognitive Function and Health-related Quality of Life
Hearing Loss, Cognitive Impairment, Mild
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Not yet recruiting
Automated Text Message Reminders to Promote Hearing Aid Adoption
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.
Marisa Frasson, Doctor study chair
Federal University of São Paulo
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 Deafness, run by Federal University of São Paulo 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 16 Sep 2008. 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.
What does the primary outcome measure?
Otoacoustic Emissions (time frame: At birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00753194, which also lists 1 linked publication.
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 16 Sep 2008.