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

April 17, 2023 updated by: Nomazulu Dlamini, The Hospital for Sick Children

International Pediatric Stroke Study

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 stroke or are at high risk of having a stroke into the registry. Participants have their medical and research records reviewed for information about their stroke and abstracted into a secure electronic database called REDCap. 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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

12000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

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

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Pediatric Stroke Outcome Measure at 3 months.
Time Frame: 3-12 months post-stroke
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
Time Frame: 3-12 months post-stroke
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)
Time Frame: 3-12 months 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.
3-12 months post-stroke
modified Rankin Scale (mRS)
Time Frame: 3-12 months post-stroke
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator-Initiated Research Studies
Time Frame: As proposed
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 (ipss.research@sickkids.ca).
As proposed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Nomazulu Dlamini, MD, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Anticipated)

December 1, 2030

Study Completion (Anticipated)

December 1, 2030

Study Registration Dates

First Submitted

June 9, 2004

First Submitted That Met QC Criteria

June 9, 2004

First Posted (Estimate)

June 10, 2004

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000070460 (Registry Identifier: The International Pediatric Stroke Study)
  • 04-N-0210 (Registry Identifier: IPSS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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