False Positive Results in Newborn Hearing Screening

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-01-31

Brief Summary

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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

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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

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Deafness

Keywords

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hearing newborn otoacoustic emissions

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Newborns that show a "Pass" On the newborn hearing screening program before hospital discharge

No interventions assigned to this group

2

Newborns that show a "fail" and will be retested in 15 days.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Healthy newborns

Exclusion Criteria

* Risk factors for hearing loss

Minimum Eligible Age

6 Hours

Maximum Eligible Age

48 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Universidade Federal de Sao Paulo

Principal Investigators

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Marisa Frasson, Doctor

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

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Hospital Panamericano

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT

PMID: 16504089 (View on PubMed)

Other Identifiers

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26129

Identifier Type: -

Identifier Source: secondary_id

2612