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False Positive Results in Newborn Hearing Screening (NHS)

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00753194
First received: September 15, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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
Deafness

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 ] [ Designated as safety issue: Yes ]

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)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   up to 48 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Newborns

Criteria

Inclusion Criteria:

  • Healthy newborns

Exclusion Criteria:

  • Risk factors for hearing loss
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753194

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

Additional Information:
Publications:
Responsible Party: Maria Cristina Silva simonek, Universidade Federal de Sao Paulo
ClinicalTrials.gov Identifier: NCT00753194     History of Changes
Other Study ID Numbers: 2612, 26129
Study First Received: September 15, 2008
Last Updated: September 15, 2008
Health Authority: Brazil: Ministry of Health

Keywords provided by Federal University of São Paulo:
hearing
newborn
otoacoustic emissions

ClinicalTrials.gov processed this record on November 27, 2014