Database for Stroke in Infants and Children: the International Pediatric Stroke Study

NCT00084292 | Recruiting

• 2 other identifiers: 100007046004-N-0210
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• Change from Pediatric Stroke Outcome Measure at 3 months.

  The Pediatric Stroke Outcome Measure (PSOM) was developed out of a need for an objective, standardized outcome measures for children with acute, unilateral focal CNS such as cerebral infarction. The goal was to develop an assessment measure that defines clinically and functionally relevant outcome in pediatric stroke. This measure was designed for and tested in children with arterial ischemic stroke or cerebral sinovenous thrombosis.

  3-12 months post-stroke

• Recovery and Recurrence Questionnaire

  The Recurrence and Recovery Questionnaire (RRQ) was developed by converting the Pediatric Stroke Outcome Measure (PSOM) into a questionnaire for patient/parent telephone interview. The agreement and consistency of the PSOM and RRQ was then assessed, and validated. The RRQ captures the same 5 sub-domains as the PSOM in the event a patient cannot return to clinic for a follow-up visit and can be used as a measure of recovery post-stroke.

  3-12 months post-stroke

• King's Outcome Scale for Childhood Head Injury (KOSCHI)

  The KOSCHI is a standardized outcome measure and was developed as a pediatric adaptation of the original adult Glasgow Outcome Scale. It is a widely used outcome measure post neurological injury in children and have been used in previous pediatric stroke research. The KOSCHI can be completed through chart review of clinical or progress notes.

  3-12 months post-stroke

• modified Rankin Scale (mRS)

  The modified Rankin Scale is a standardized outcome measure that captures the degree of disability in patients who have had a stroke. It is widely used in previous pediatric stroke research to assess global neurological impairment following stroke in children. It is a single-item scale and can be completed through chart review of clinical or progress notes.

  3-12 months post-stroke

Secondary Outcomes (1)

• Investigator-Initiated Research Studies

  As proposed

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Hospital For Sick Children

Toronto, Ontario, Canada

RECRUITING

Related Publications (4)

• 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.

  PMID: 11773550 BACKGROUND

• 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.

  PMID: 10830198 BACKGROUND

• 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.

  PMID: 11496852 BACKGROUND

• 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.

  PMID: 18787197 BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemia; Ischemic Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Paralysis; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Nomazulu Dlamini, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IPSS Central

CONTACT

416-813-7654; ipss.research@sickkids.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician, Neurology

Study Record Dates

• First Submitted: June 9, 2004
• First Posted: June 10, 2004
• Study Start: January 1, 2003
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)