Database for Stroke in Infants and Children: the International Pediatric Stroke Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorThe Hospital for Sick Children
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Arterial Ischemic Stroke (AIS),
Cerebral Sinovenous Thrombosis (CSVT),
AIS and CSVT
Presume Preinatal Ischemic Stroke (PPIS)
Disqualifiers
Premature children diagnosed with AIS.
Premature children diagnosed with PPIS
Children diagnosed with TIA (Transient Ischemic Attack)
Brain hemorrhage secondary to trauma
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
3-12 months post-stroke2
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.
Time frame
3-12 months post-stroke3
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.
Time frame
3-12 months post-stroke4
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.
Time frame
3-12 months post-strokeSecondary outcomes
1
Investigator-Initiated Research Studies
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]).
Time frame
As proposedSponsors and contacts
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Source ClinicalTrials.gov