Database for Stroke in Infants and Children
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.
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||12 Months|
|Official Title:||International Pediatric Stroke Study|
- Pediatric Stroke outcome Measure [ Time Frame: 3 and 12 months post-stroke ] [ Designated as safety issue: No ]
- discharge destination [ Time Frame: at discharge ] [ Designated as safety issue: No ]
|Study Start Date:||June 2004|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||December 2020 (Final data collection date for primary outcome measure)|
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 over 70 centers worldwide. 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00084292
|Contact: IPSS Cofirstname.lastname@example.org|
|Hospital For Sick Children||Recruiting|
|Toronto, Ontario, Canada|
|Contact: IPSS Co-ordinator email@example.com|