False Positive Results in Newborn Hearing Screening (NHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00753194
Recruitment Status : Completed
First Posted : September 16, 2008
Last Update Posted : September 16, 2008
Information provided by:
Federal University of São Paulo

Brief 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.

Condition or disease

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
Actual Enrollment : 1110 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: False-Positive Results in Newborn Hearing Screening: Possible Causes
Study Start Date : March 2005
Actual Primary Completion Date : March 2006
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Newborns that show a "Pass" On the newborn hearing screening program before hospital discharge
Newborns that show a "fail" and will be retested in 15 days.

Primary Outcome Measures :
  1. Otoacoustic Emissions [ Time Frame: At birth ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Inclusion Criteria:

  • Healthy newborns

Exclusion Criteria:

  • Risk factors for hearing loss

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00753194

Hospital Panamericano
Rio de Janeiro, Brazil, 22.220-001
Sponsors and Collaborators
Federal University of São Paulo
Study Chair: Marisa Frasson, Doctor Federal University of São Paulo

Publications of Results:
Responsible Party: Maria Cristina Silva simonek, Universidade Federal de Sao Paulo Identifier: NCT00753194     History of Changes
Other Study ID Numbers: 2612
First Posted: September 16, 2008    Key Record Dates
Last Update Posted: September 16, 2008
Last Verified: September 2008

Keywords provided by Federal University of São Paulo:
otoacoustic emissions

Additional relevant MeSH terms:
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms