False Positive Results in Newborn Hearing Screening - Full Text View

Sponsored by:	Federal University of São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00753194

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

Genetics Home Reference related topics: nonsyndromic deafness

MedlinePlus related topics: Hearing Disorders and Deafness

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional
Official Title:	False-Positive Results in Newborn Hearing Screening: Possible Causes

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

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

Universidade Federal de Sao Paulo

More Information

Non profitable organization that implemented Newborn Hearing Screening in Brazil This link exits the ClinicalTrials.gov site

Publications of Results:

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.

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

Keywords provided by Federal University of São Paulo:

hearing
newborn
otoacoustic emissions

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Deafness

Otorhinolaryngologic Diseases
Neurologic Manifestations
Hearing Loss
Ear Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009