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False Positive Results in Newborn Hearing Screening (NHS)

This study has been completed.
Information provided by:
Federal University of São Paulo Identifier:
First received: September 15, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
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 Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: False-Positive Results in Newborn Hearing Screening: Possible Causes

Resource links provided by NLM:

Further study details as provided by Federal University of São Paulo:

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

Enrollment: 1110
Study Start Date: March 2005
Study Completion Date: January 2007
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
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.

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.

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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Maria Cristina Silva simonek, Universidade Federal de Sao Paulo Identifier: NCT00753194     History of Changes
Other Study ID Numbers: 2612
Study First Received: September 15, 2008
Last Updated: September 15, 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 processed this record on September 21, 2017