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Database for Stroke in Infants and Children

This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), April 2008

Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00084292
  Purpose

This multi-center collaborative study will establish a database of information about stroke in infants and children.

Children 0 to 18 years of age who: 1) have had an ischemic stroke after January 1, 2003; 2) have a history of spastic hemiplegic or quadriplegic cerebral palsy and X-ray evidence of ischemic stroke after January 1, 2003; or 3) are diagnosed with ischemic stroke defined by a new focal neurologic deficit lasting 24 hours or more and presumed due to vessel obstruction or narrowing may be eligible to participate this study.

Participating children have their medical and research records reviewed for information about their stroke. The information is gathered and entered into an internet database. Parents may be interviewed to obtain additional information, if needed. No identifying information is entered into the database, so that the child's participation remains anonymous. The resulting registry may allow physicians to better diagnose, treat, and prevent stroke in children, and will help in developing and conducting new clinical trials to study this disease.


Condition
Cerebrovascular Accident

Genetics Home Reference related topics:   Stroke  

MedlinePlus related topics:   Cerebral Palsy  

U.S. FDA Resources

Study Type:   Observational
Official Title:   Towards the Establishment of Standards of Practice and the Initiation of Multi-Center, Multi-National Clinical Trials for Neonates and Children With Stroke

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:   50
Study Start Date:   June 2004

Detailed Description:

OBJECTIVES: This is the first multi-center, multi-national study of children with stroke. It seeks to build a network of investigators, and baseline disease data, to enable childhood stroke clinical trials to be developed.

STUDY POPULATION: Infants and children with ischemic stroke (arterial ischemic stroke and sinovenous thrombosis).

DESIGN: This study is a prospective cohort study conducted consecutively at ten United States, United Kingdom, European, and Canadian centers. This cohort will be used to develop and apply standardized protocols in a study setting for the diagnosis, etiological investigation, treatment, and outcome assessment of infants and children with ischemic stroke (arterial ischemic stroke and sinovenous thrombosis). Children, with diagnosis of stroke made after January 2003, will be prospectively enrolled into a web-based data entry system, over a two-year period.

OUTCOME MEASURES: This study will quantify outcome event rates (initial stroke characteristics, recurrent stroke, mortality, neurologic deficits), which can be used in designing future intervention studies and determining sample sizes. Analysis will be primarily descriptive. Some predictor testing for outcomes within strata may be utilized for web-based data.

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

Criteria
  • INCLUSION CRITERIA:

Children, 0 to 18 years of age, with an event of ischemic stroke after January 1, 2003;

Children, 0 to 18 years of age, with a history of spastic hemiplegic or quadriplegic cerebral palsy with radiographic evidence of ischemic stroke occurring after January 1, 2003;

A diagnosis of ischemic stroke (arterial ischemic stroke or sinovenous thrombosis) as defined by a new focal neurologic deficit lasting greater than or equal to 24 hours and presumably due to a vascular process and confirmed by brain imaging, either computed tomography (CT), magnetic resonance (MR), or Doppler ultrasonography;

Informed consent of the parent; and

Informed assent of the child, when available.

EXCLUSION CRITERIA:

Preterm children (less than 36 weeks gestation);

Children greater than 18 years of age;

Children with an event of ischemic stroke prior to January 1, 2003.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084292

Contacts
Contact: Patient Recruitment and Public Liaison Office     (800) 411-1222     prpl@mail.cc.nih.gov    
Contact: TTY     1-866-411-1010    

Locations
United States, California
University of California, Los Angeles     Recruiting
      Los Angeles, California, United States, 90095
United States, New York
Mt. Sinai Medical Center     Recruiting
      New York, New York, United States, 10029-0574
United States, North Carolina
Wake Forest University     Recruiting
      Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Childrens Hospital, Philadelphia     Recruiting
      Philadelphia, Pennsylvania, United States, 19104
Belgium
Cliniques Universitaires Saint-Luc     Recruiting
      Brussels, Belgium
Canada
Hospital For Sick Children Research Institute     Recruiting
      Toronto, Canada
United Kingdom
Institute of Child Health     Recruiting
      London, United Kingdom

Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   040210, 04-N-0210
First Received:   June 9, 2004
Last Updated:   May 7, 2008
ClinicalTrials.gov Identifier:   NCT00084292
Health Authority:   United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Ischemia  
Pediatric  
Etiology  
Treatment  
Outcome  
Childhood Stroke
Pediatric Stroke
Ischemic Stroke
Spastic Hemiplegia
Quadriplegic Cerebral Palsy

Study placed in the following topic categories:
Hemiplegia
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases
Cerebrovascular Disorders
Paralysis
Cerebral Palsy
Brain Ischemia
Brain Infarction
Infarction

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 03, 2008




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