National Egyptian Network Pediatric Stroke and Hemiplegia Registry

Perinatal Stroke Clinical Trial

Official title:

National Egyptian Network Pediatric Stroke and Hemiplegia Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02129491
• Other study ID #: NENPSHR
• Status: Recruiting
• Phase: N/A
• First received: April 15, 2014
• Last updated: May 1, 2014
• Start date: January 2014
• Est. completion date: December 2021

Study information

• Verified date: May 2014
• Source: Ain Shams University
• Contact: Sahar MA Hassanein, MD, PhD
• Phone: 201223183943
• Email: saharhassanein[@]med.asu.edu.eg
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2021
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Focal Neurologic Deficits
• Hemiplegia
• Perinatal Stroke
• Stroke
• Stroke With Hemiparesis

Locations

Country	Name	City	State
Egypt	Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University	Cairo	Abassia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Long term neurological deficit	Post-stroke pediatric gross and fine motor function will be assessed.	12 months	No

External Links

•   Ain Shams University web site
•   Faculty of Medicine, Ain Shams University