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NCT00753194 Clinical Trial

False Positive Results in Newborn Hearing Screening

Deafness Clinical Trial

— NHS  

Official title:
False-Positive Results in Newborn Hearing Screening: Possible Causes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00753194
Other study ID # 2612
Secondary ID 26129
Status Completed
Phase N/A
First received September 15, 2008
Last updated September 15, 2008
Start date March 2005
Est. completion date January 2007

Study information
Verified date September 2008
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of Health
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1110
Est. completion date January 2007
Est. primary completion date March 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 48 Hours
Eligibility Inclusion Criteria:

- Healthy newborns

Exclusion Criteria:

- Risk factors for hearing loss

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Brazil Hospital Panamericano Rio de Janeiro

Sponsors (1)
Lead Sponsor Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Otoacoustic Emissions At birth Yes
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