Clinical Trial: Database for Stroke in Infants and Children


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Sponsored by:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	Warren G Magnuson Clinical Center (CC)

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.

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

Condition
Cerebrovascular Accident

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.

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.