Demographic Characteristics of Children Suffering From Me... | NCT02214745

Studies
Demographic Characteristics of Children Suffering From Mental Retardation or Cerebral Palsy in the Israeli Arab Community

NCT02214745

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Aug 12, 2014Estimated

Enrollment

400Estimated

Phase

Not provided

Conditions

Mental Retardation
Cerebral Palsy

Interventions

Questionnaire

Countries

Israel

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

Aug 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Oct 2016Estimated

Completion Date

Mar 2017Estimated

First Submitted Date

Aug 11, 2014

First Submission Date that Met QC Criteria

Aug 11, 2014

First Posted Date

Aug 12, 2014Estimated

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

Aug 11, 2014

Last Update Posted Date

Aug 12, 2014Estimated

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

To evaluate the demographic characteristics of patients suffering from mental retardation or cerebral palsy in the Israeli Arab community. Specific questionnaires will be developed and will be distributed amongst this population in order to identify these characteristics.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mentally retarded Israeli Arab children			Other: Questionnaire
Israeli Arab children with cerebral palsy			Other: Questionnaire
Israeli Jewish children with cerebral palsy			Other: Questionnaire
Mentally retarded Israeli Jewish children			Other: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	Questionnaire developed for this purpose by the investigators	Israeli Arab children with cerebral palsy Israeli Jewish children with cerebral palsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Demographic Characteristics	Demographic characteristics will be identified through a questionnaire and will be compared with control groups.	One day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cerebral palsy
mental retardation
Israeli Arab
Israeli Jewish

Exclusion Criteria:

all others

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Israeli Arab and Israeli Jewsih children suffering from mental retardation or cerebral palsy who have presented at the Child Development Institute at the Hillel Yaffe Medical Center.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Muhammad Mahajnah, MD, PhD	Contact	972-5-624-6959		mohamedm@hy.health.gov.il

Overall Officials

Name	Affiliation	Role
Muhammad Mahajnah, MD, PhD	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D008607	Intellectual Disability
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided