Functional Endoscopic Evaluation of Swallowing | NCT00717028

Studies
Functional Endoscopic Evaluation of Swallowing

NCT00717028

Sponsor

Fortaleza University

Status

Completed

Last Update Posted

Jul 16, 2008Estimated

Enrollment

9Actual

Phase

Not provided

Conditions

Cerebral Palsy
Dysphagia

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

Sep 2005

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

Sep 2005

Primary Completion Date

Nov 2005Actual

Completion Date

Nov 2005Actual

First Submitted Date

Jul 14, 2008

First Submission Date that Met QC Criteria

Jul 14, 2008

First Posted Date

Jul 16, 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

Jul 14, 2008

Last Update Posted Date

Jul 16, 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

The investigators objective is to describe functional endoscopic evaluation of swallowing findings in children with cerebral palsy.

Detailed Description

Cerebral palsy (CP) is a predominantly motor disorder and dysphagia is a frequent complaint. Functional endoscopic evaluation of swallowing (FESS) involves anatomic and functional observation of the larynx and pharynx, evaluation of swallowing and maneuvers to improve it, also testing the laryngeal sensitivity. We evaluated nine patients with CP of both sexes, which age varied from 1 to 10 years old, attended at dysphagia multidisciplinary clinic, at NAMI (Integrated Medical Assistance Nucleons).

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

9Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

medical diagnosis of cerebral palsy.

Exclusion Criteria:

medical diagnoses not associated with cerebral palsy that affect swallowing.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

10 Years

Standard Ages

Child

Study Population

Children with cerebral palsy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Renata Haguette, Mestre	Fortaleza University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dysphagia multidisciplinary clinic at Integrated Medical Assistance Nucleons		Fortaleza	Ceará		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy
D003680	Deglutition Disorders

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided