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National Egyptian Network Pediatric Stroke and Hemiplegia Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Ain Shams University
Sponsor:
Information provided by (Responsible Party):
Sahar M.A. Hassanein, MD, Ain Shams University
ClinicalTrials.gov Identifier:
NCT02129491
First received: April 15, 2014
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

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.


Condition
Stroke With Hemiparesis
Perinatal Stroke
Focal Neurologic Deficits

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: National Egyptian Network Pediatric Stroke and Hemiplegia Registry

Resource links provided by NLM:


Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Children with acute stroke will be followed till either death or discharge from hospital, all clinical, radiological and therapeutic data will be collected.


Secondary Outcome Measures:
  • Long term neurological deficit [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Post-stroke pediatric gross and fine motor function will be assessed.


Estimated Enrollment: 1000
Study Start Date: January 2014
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pediatric Stroke and Hemiplegia
Any infant or child with acute stroke or hemiplegia

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

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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:

  1. Cerebral haemorrhage not associated with ischemic infarct.
  2. Hypoxic ischemic event with diffuse or bilateral infarction alone.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02129491

Contacts
Contact: Sahar MA Hassanein, MD, PhD 201223183943 saharhassanein@med.asu.edu.eg

Locations
Egypt
Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University Recruiting
Cairo, Abassia, Egypt, 11381
Contact: Mohsen S Elalfy, MD, PhD       elalfym@hotmail.com   
Principal Investigator: Sahar MA Hassanein, MD, PhD         
Sponsors and Collaborators
Ain Shams University
Investigators
Study Chair: Sahar MA Hassanein, MD, PhD Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University
  More Information

Additional Information:
No publications provided

Responsible Party: Sahar M.A. Hassanein, MD, Professor of Pediatrics, Ain Shams University
ClinicalTrials.gov Identifier: NCT02129491     History of Changes
Other Study ID Numbers: NENPSHR
Study First Received: April 15, 2014
Last Updated: May 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ain Shams University:
stroke
Congenital stroke
neonatal
hemiplegia

Additional relevant MeSH terms:
Cerebral Infarction
Hemiplegia
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Neurologic Manifestations
Paralysis
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014