False Positive Results in Newborn Hearing Screening (NHS)

September 15, 2008 updated by: Federal University of São Paulo

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1110

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

  • Brazil
      • Rio de Janeiro, Brazil, 22.220-001
        • Hospital Panamericano

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

6 hours to 2 days (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newborns

Description

Inclusion Criteria:

  • Healthy newborns

Exclusion Criteria:

  • Risk factors for hearing loss

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
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Otoacoustic Emissions
Time Frame: At birth
At birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Study Chair: Marisa Frasson, Doctor, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2005

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

September 15, 2008

First Submitted That Met QC Criteria

September 15, 2008

First Posted (Estimate)

September 16, 2008

Study Record Updates

Last Update Posted (Estimate)

September 16, 2008

Last Update Submitted That Met QC Criteria

September 15, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2612
  • 26129

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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