Recruiting
IPSS

International Pediatric Stroke Study

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Brain Diseases
+4

+ Cardiovascular Diseases
+ Central Nervous System Diseases
Until 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: January 2003
See protocol details

Summary

Principal SponsorThe Hospital for Sick Children
Study ContactIPSS Central
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2003Actual date on which the first participant was enrolled.

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.

Official TitleInternational Pediatric Stroke Study 
NCT00084292
Principal SponsorThe Hospital for Sick Children
Study ContactIPSS Central
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
12000 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

How participants are selected
Participants are chosen using a random method, so everyone has a known and fair chance of being selected. This approach helps ensure the results reflect the broader population.
Another way to select participants is through a non-probability sample, where participants are selected without randomization, often based on availability or willingness to take part.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.

Other Ways to Collect Data
Retrospective: These studies use existing medical records or past data.
Cross-sectional: These studies collect data at one single point in time.
Others: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Until 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Stroke
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

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.

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.

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.

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.
Secondary Objectives

Participating in the IPSS gives investigators permission to conduct multi-site research studies, in accordance with the Publications Committee policy. Manuscripts published to date can be accessed through IPSS Central ([email protected]).

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Hospital For Sick ChildrenToronto, CanadaSee the location
Recruiting
One Study Center