National Egyptian Network Pediatric Stroke and Hemiplegia Registry

May 1, 2014 updated by: Sahar M.A. Hassanein, MD, Ain Shams University
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.

Study Overview

Status

Unknown

Conditions

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

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abassia
      • Cairo, Abassia, Egypt, 11381
        • Recruiting
        • Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University
        • Contact:
        • Principal Investigator:
          • Sahar MA Hassanein, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Pediatric Stroke and Hemiplegia
Any infant or child with acute stroke or hemiplegia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival or neurologic deficit after acute cerebrovascular stroke.
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

May 1, 2014

First Posted (Estimate)

May 2, 2014

Study Record Updates

Last Update Posted (Estimate)

May 2, 2014

Last Update Submitted That Met QC Criteria

May 1, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NENPSHR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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