NCT02129491

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 2, 2014

Status Verified

May 1, 2014

Enrollment Period

6 years

First QC Date

April 15, 2014

Last Update Submit

May 1, 2014

Conditions

Keywords

strokeCongenital strokeneonatalhemiplegia

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Long term neurological deficit

    12 months

Study Arms (1)

Pediatric Stroke and Hemiplegia

Any infant or child with acute stroke or hemiplegia

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University

Cairo, Abassia, 11381, Egypt

RECRUITING

Related Links

MeSH Terms

Conditions

Neurologic ManifestationsStrokeHemiplegia

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysis

Study Officials

  • Sahar MA Hassanein, MD, PhD

    Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University

    STUDY CHAIR

Central Study Contacts

Sahar MA Hassanein, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

April 15, 2014

First Posted

May 2, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2020

Study Completion

December 1, 2021

Last Updated

May 2, 2014

Record last verified: 2014-05

Locations