Clinical and Instrumental Evaluation of Swallowing in Chi... | NCT01031771

Studies
Clinical and Instrumental Evaluation of Swallowing in Children With Cerebral Palsy

NCT01031771

Sponsor

Fortaleza University

Status

Completed

Last Update Posted

Dec 15, 2009Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Cerebral Palsy
Deglutition Disorders

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

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

Feb 2009

Primary Completion Date

Not provided

Completion Date

Nov 2009Actual

First Submitted Date

Dec 12, 2009

First Submission Date that Met QC Criteria

Dec 14, 2009

First Posted Date

Dec 15, 2009Estimated

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

Dec 14, 2009

Last Update Posted Date

Dec 15, 2009Estimated

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 purpose of this study is to correlate the alimentary consistencies and deglutition disorders in children with cerebral palsy.

Detailed Description

Cross-sectional and quantitative study with sample consisted of 50 children with cerebral palsy. The data collection consisted in detection of the main dysphagic manifestations in different consistency of food and types of cerebral palsy.

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

50Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children with Cerebral Palsy diagnoses were involved, independent from the pre, peri and postnatal factors and from the type of Cerebral Palsy

Exclusion Criteria:

Children who presented oropharyngelarynx structural abnormality and/or impossibility to feed by oral way

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

5 Years

Standard Ages

Child

Study Population

Children with Cerebral Palsy diagnoses

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Moisés A Queiroz, Graduate	Fortaleza University	Principal Investigator

Locations

Not provided

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