National Egyptian Network Pediatric Stroke and Hemiplegia... | NCT02129491

Studies
National Egyptian Network Pediatric Stroke and Hemiplegia Registry

NCT02129491

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

May 2, 2014Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Stroke With Hemiparesis
Perinatal Stroke
Focal Neurologic Deficits

Interventions

Not provided

Countries

Egypt

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

May 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jan 2020Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Apr 15, 2014

First Submission Date that Met QC Criteria

May 1, 2014

First Posted Date

May 2, 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

May 1, 2014

Last Update Posted Date

May 2, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sahar M.A. Hassanein, MD, Professor of Pediatrics, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

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

Our aim is to establish multi-center national Egyptian database of information about cerebrovascular stroke and hemiplegia in infants and children from 0 to 18 years of age.

Detailed Description

Aims: An open-ended multi-center, national Egyptian study to collect and analyze data for children with cerebrovascular stroke and hemiplegia .

Participants: Eligible infants and children with stroke and hemiplegia.

DESIGN: This study is a prospective cohort study.

Primary outcome measure: Initial acute stroke clinical and radiological presentation, recurrent stroke, mortality, and neurologic deficits in the acute stage, participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pediatric Stroke and Hemiplegia		Any infant or child with acute stroke or hemiplegia

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival or neurologic deficit after acute cerebrovascular stroke.	Children with acute stroke will be followed till either death or discharge from hospital, all clinical, radiological and therapeutic data will be collected.	participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Long term neurological deficit	Post-stroke pediatric gross and fine motor function will be assessed.	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Focal neurological deficit of acute onset lasting greater than 20 minutes. And CT or MRI showing infarct in location consistent with neurological signs and symptoms
Hemiplegia

Exclusion Criteria:

Cerebral haemorrhage not associated with ischemic infarct.
Hypoxic ischemic event with diffuse or bilateral infarction alone.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

All children from birth to 18 years of age with acute stroke presented by focal neurological signs confirmed by neuroradiology CT or MRI. All children with hemiplegia till the age of 18 years.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sahar MA Hassanein, MD, PhD	Contact	201223183943		saharhassanein@med.asu.edu.eg

Overall Officials

Name	Affiliation	Role
Sahar MA Hassanein, MD, PhD	Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University	Recruiting	Cairo	Abassia	11381	Egypt

References Module

Citations

Not provided

Label	URL
Faculty of Medicine, Ain Shams University	View source
Ain Shams University web site	View source

ID	Term
D009461	Neurologic Manifestations
D020521	Stroke
D006429	Hemiplegia

ID	Term
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D002561	Cerebrovascular Disorders