Clinical trial NCT00084292: Database for Stroke in Infants and Children: the International Pediatric Stroke Study
Official title: International Pediatric Stroke Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebrovascular Accident
Focal Infarct
Keywords: Ischemia
Pediatric
Etiology
Treatment
Outcome
Childhood Stroke
Pediatric Stroke
Ischemic Stroke
Spastic Hemiplegia
Hemiplegic cerebral palsy
Neonatal Stroke
Neuroimaging
Arteriopathy
Hemorrhagic
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2004-06-10
Enrollment: 12000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neonates (\<28 days) and children (\>29 days) to 18 years old with arterial ischemic stroke, cerebral sinovenous thrombosis, hemorrhagic stroke or at high risk of stroke

Brief summary: The International Pediatric Stroke Study (IPSS) was established in 2003 as a multi-center, multi-national clinical research registry. Over the years, it has grown to become a highly successful study vehicle for pediatric stroke research across over 100 institutions worldwide. Today, The IPSS continues to serve as the global clinical data and imaging core for multi-disciplinary pediatric experts who perform international collaborative research to better understand, prevent, and improve outcomes in pediatric stroke. The robust dataset and cohesive network enable high caliber and ground-breaking research in the field.

Participating sites enroll neonates or children who have had an ischemic or hemorrhagic stroke, or may be at high risk of having a stroke. Participants have their medical and research records reviewed for information about their stroke and abstracted into a secure electronic database called REDCap, which is hosted at SickKids in Toronto Canada. The IPSS also provides an attractive imaging platform (through the Stroke Imaging Lab for Children, SILC, housed at SickKids) for sites to share clinically acquired brain images that will complement the clinical dataset. The clinical and imaging datasets will improve our understanding of the processes underlying plasticity and recovery in childhood stroke.

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 high-quality disease dataset to enable population-based studies, natural history studies, and clinical trials to improve the care of children with stroke.

STUDY POPULATION: Infants and children with ischemic stroke (arterial ischemic stroke and cerebral sinovenous thrombosis), hemorrhagic stroke or those at high risk (e.g. arteriopathies like moyamoya).

DESIGN: This study includes a data collection component and collaborative process. Our network of over 150 investigators prospectively collect data on neonates or children with a diagnosis of stroke made after January 2003. Data on stroke diagnosis, etiology, treatment and outcomes are collected and entered into a secure web system, REDCap. Neuro-imaging data from the index event and a series of follow-up time points are captured and stored in the SILC-IPSS data repository.

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. Participating investigators submit investigator-initiated research proposals or grants with a specific focus, leveraging the clinical and imaging dataset.

Eligibility criteria: Inclusion Criteria:

This registry will include all children from birth to 18 years of age who are diagnosed with stroke or a condition/disease (as defined below) that put them at high risk of stroke after Jan 1,2003 at one of the IPSS participating sites.

This registry will include children diagnosed with below stroke types:

* Arterial Ischemic Stroke (AIS),
* Cerebral Sinovenous Thrombosis (CSVT),
* AIS and CSVT
* Presume Preinatal Ischemic Stroke (PPIS)
* Children diagnosed with hemorrhagic stroke

Children at high risk of stroke include:

* Those diagnosed with arteriopathy, arteritis/vasculitis, moyamoya, dissection, sickle cell related infarcts).
* Brain arteriovenous malformations

Exclusion Criteria:

* Premature children diagnosed with AIS.
* Premature children diagnosed with PPIS
* Children diagnosed with TIA (Transient Ischemic Attack)
* Brain hemorrhage secondary to trauma
* Refusal to provide consent for participation

Primary outcomes:
measure: Change from Pediatric Stroke Outcome Measure at 3 months.
timeFrame: 3-12 months post-stroke
measure: Recovery and Recurrence Questionnaire
timeFrame: 3-12 months post-stroke
measure: King's Outcome Scale for Childhood Head Injury (KOSCHI)
timeFrame: 3-12 months post-stroke
measure: modified Rankin Scale (mRS)
timeFrame: 3-12 months post-stroke
Secondary outcomes:
measure: Investigator-Initiated Research Studies
timeFrame: As proposed
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital For Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Nomazulu Dlamini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lynch JK, Hirtz DG, DeVeber G, Nelson KB. Report of the National Institute of Neurological Disorders and Stroke workshop on perinatal and childhood stroke. Pediatrics. 2002 Jan;109(1):116-23. doi: 10.1542/peds.109.1.116.
citation: deVeber GA, MacGregor D, Curtis R, Mayank S. Neurologic outcome in survivors of childhood arterial ischemic stroke and sinovenous thrombosis. J Child Neurol. 2000 May;15(5):316-24. doi: 10.1177/088307380001500508.
citation: deVeber G, Andrew M, Adams C, Bjornson B, Booth F, Buckley DJ, Camfield CS, David M, Humphreys P, Langevin P, MacDonald EA, Gillett J, Meaney B, Shevell M, Sinclair DB, Yager J; Canadian Pediatric Ischemic Stroke Study Group. Cerebral sinovenous thrombosis in children. N Engl J Med. 2001 Aug 9;345(6):417-23. doi: 10.1056/NEJM200108093450604.
citation: Golomb MR, Fullerton HJ, Nowak-Gottl U, Deveber G; International Pediatric Stroke Study Group. Male predominance in childhood ischemic stroke: findings from the international pediatric stroke study. Stroke. 2009 Jan;40(1):52-7. doi: 10.1161/STROKEAHA.108.521203. Epub 2008 Sep 11.