Middle and Inner Ear Malformation in Children With Veloca... | NCT00784173

Studies
Middle and Inner Ear Malformation in Children With Velocardiofacial Syndrome

NCT00784173

Sponsor

Pontificia Universidade Catolica de Sao Paulo

Status

Completed

Last Update Posted

Nov 3, 2008Estimated

Enrollment

2Actual

Phase

Not provided

Conditions

Ear Malformations in the Velocardiofacial Syndrome

Interventions

Not provided

Countries

Not provided

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

Oct 2008

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 2007

Primary Completion Date

Mar 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

Oct 31, 2008

First Submission Date that Met QC Criteria

Oct 31, 2008

First Posted Date

Nov 3, 2008Estimated

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

Oct 31, 2008

Last Update Posted Date

Nov 3, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Middle and inner ear malformations on two boys with velocardiofacial syndrome are discussed.Special attention should be given to the presence of hearing loss due to middle and inner ear malformations, in addition to frequent conductive hearing loss regarding mastoid and middle ear inflammatory processes.

Detailed Description

Two boys with clinical signs of velocardiofacial syndrome, at ages of 4.7 and 6,7 years old are the subjects of this study.Audiological evaluation, including pure tone audiometry, tympanometry, acoustical reflex, and Computerized Tomography of temporal bones, and analyses of DNA sample with markers of 22q11 region were performed.

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

2Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with velocardiofacial syndrome

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Children with velocardiofacial syndrome

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alfredo Tabith-Junior, MD	Pontificia Universidade Católica de São Paulo	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013577	Syndrome
D000013	Congenital Abnormalities

Ancestor Terms

ID	Term
D004194	Disease
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided