NCT01113450

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,148

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2010

Completed
Last Updated

April 30, 2010

Status Verified

December 1, 2009

Enrollment Period

1.9 years

First QC Date

April 29, 2010

Last Update Submit

April 29, 2010

Conditions

Keywords

hearing, newborn, screening

Eligibility Criteria

Age2 Days - 3 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

There were two groups: 1. high risk for hearing loss 2. low risk for hearing loss

You may qualify if:

  • middle ear conditions integrates

You may not qualify if:

  • middle ear conditions inadequate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEDAC

Cuiabá, Mato Grosso, 78000000, Brazil

Location

Study Officials

  • Priscila L Rodrigues, PHD student

    Centro de Diagnostico Auditivo de Cuiaba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 29, 2010

First Posted

April 30, 2010

Study Start

January 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 30, 2010

Record last verified: 2009-12

Locations