Results of a Program of Newborn Hearing Screening (NHS) i... | NCT01113450

Studies
Results of a Program of Newborn Hearing Screening (NHS) in Cuiaba-Brazil

NCT01113450

Sponsor

Centro de Diagnostico Auditivo de Cuiaba

Status

Completed

Last Update Posted

Apr 30, 2010Estimated

Enrollment

3,148Actual

Phase

Not provided

Conditions

Showing the Results of a Program of NHS in Cuiaba_ Brazil

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Apr 29, 2010

First Submission Date that Met QC Criteria

Apr 29, 2010

First Posted Date

Apr 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2010

Last Update Posted Date

Apr 30, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study aims to demonstrate the indices of quality of a Newborn Hearing Screening (NHS).

Detailed Description

The data refer to infants underwent newborn hearing screening by evoked otoacoustic emissions by transient stimulation, using the analyzer EOA Biologic. Examinations archived in the computer's service were analyzed for the amount of infants who passed or failed the screening, as well as the correlations with the same age and gender.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,148Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

middle ear conditions integrates

Exclusion Criteria:

middle ear conditions inadequate

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Days

Maximum Age

3 Months

Standard Ages

Child

Study Population

There were two groups:

high risk for hearing loss
low risk for hearing loss

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Priscila L Rodrigues, PHD student	Centro de Diagnostico Auditivo de Cuiaba	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CEDAC		Cuiabá	Mato Grosso	78000000	Brazil