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

Amendment history

1. May 12, 2025

   Minor

   Study Status, Oversight, Study Description, IPDSharing

   Re-verified, no change to tracked fields

   v34

2. Apr 17, 2023

   Notable

   Primary endpoints: 2 to 4

   Eligibility criteria shortened, about 241 words; Study description expanded, about 4 words

   Show what changed: Primary endpoints

   King's Outcome Scale for Childhood Head Injury (KOSCHI) modified Rankin Scale (mRS)

   Show what changed: Eligibility criteria

   Inclusion Criteria Arterial Ischemic Stroke (AIS): EventThis diagnosis:registry Diagnosed after Jan 1, 2003 Age: Patient between >36 weeks and 18 years of age Notes: preterm included if stroke onset was in childhood Clinical Criteria: Focal neurological deficit of acute onset lasting greater than 20 minutes Radiological Criteria: CT /MRI showing infarct in location consistent w [...] will include Hypoxicall ischemicchildren eventfrom with diffuse or bilateral infarction if there is a definite focal, single arterial infarct in a specified vascular territory. Cerebral Sinovenous Thrombosis (CSVT): Even [...] [...]

   Show what changed: Study description

   [...] o build a network of investigators and high-quality disease datadataset to enable population-based studies, natural history studies [...] terial 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 a [...]

   Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Outcome Measures, Eligibility, Contacts/Locations · v33

3. May 25, 2020

   Notable

   Primary and study completion dates: Dec 2020 to Dec 2030

   Eligibility criteria expanded, about 12 words; Secondary endpoint revised; Primary endpoints revised (2); and 4 more

   Show all 8 changes in this update

   • Notable Primary and study completion dates: Dec 2020 to Dec 2030
   • Minor Eligibility criteria expanded, about 12 words
     Show what changed

     Inclusion Criteria Arterial Ischemic Stroke (AIS): •Event Adiagnosis: patientDiagnosed willafter beJan eligible1, for the study if s/he meets all of the following criteria for each stroke type: AIS2003 Age: termPatient birth (gestationbetween >36 weeks) toand 18 years of age Notes: preterm included if stroke onset was in childhood EventClinical diagnosedCriteria: after January 1st, 2003 Must have both clinical and radiological evidence present Focal neurological deficit of acute onset lasting greater than 20 minutes. ANDRadiological computedCriteria: tomographyCT (CT) or magnetic resonance ima [...] [...]
   • Minor Secondary endpoint revised
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     DischargeInvestigator-Initiated destinationResearch Studies
   • Minor Primary endpoints revised (2)
     Show what changed

     Change from Pediatric Stroke Outcome Measure at 3 months.
   • Minor Study description expanded, about 20 words
     Show what changed

     [...] th stroke. It seeks to build a network of investigators and baselinehigh-quality disease data to enable childhoodpopulation-based strokestudies, natural history studies, and clinical trials to beimprove developedthe care of children with stroke. STUDY POPULATION: Infants and children with ischemic stroke (arterial ischemic stroke and cerebral sinovenous thrombosis), or those at high risk (e.g. arteriopathies). DESIGN: This study is composed ofincludes a data collection component and collaborative process. Our network of over 150 active Investigators retrospectively and/orinvestigators prospect [...] [...]
   • Minor Site contact updated
   • Minor Collaborators shortened, about 8 words
     Show what changed

     National Institute of Neurological Disorders and Stroke (NINDS)
   • Minor Study title expanded, about 5 words
     Show what changed

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

   Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Outcome Measures, Eligibility, Contacts/Locations · v32

4. Jun 22, 2017

   Notable

   Primary endpoints: 1 to 2

   Start date: Jun 2004 to Jan 2003; Eligibility criteria expanded, about 218 words; Secondary endpoint revised; and 2 more

   Show all 6 changes in this update

   • Notable Primary endpoints: 1 to 2
     Show what changed

     Change from Pediatric Stroke outcomeOutcome Measure at 3 months Recovery and Recurrence Questionnaire
   • Minor Start date: Jun 2004 to Jan 2003
   • Minor Eligibility criteria expanded, about 218 words
     Show what changed

     INCLUSIONInclusion CRITERIACriteria: Children,• 0A patient will be eligible for the study if s/he meets all of the following criteria for each stroke type: AIS Age: term birth (gestation > 36 weeks) to 18 years of age, Event with an event of ischemic strokediagnosed after January 11st, 2003; ChildrenMust have both clinical and radiological evidence present Focal neurological deficit of acute onset lasting greater than 20 minutes. AND computed tomography (CT) or magnetic resonance imaging (MRI) showing infarct in location consistent with neurological signs and symptoms. Neonates: seizures or le [...] [...]
   • Minor Secondary endpoint revised
     Show what changed

     dischargeDischarge destination
   • Minor Study description expanded, about 4 words
     Show what changed

     [...] en with stroke. It seeks to build a network of investigators, and baseline disease data, to enable childhood stroke clinical trials to be developed. [...] ic stroke and sinovenous thrombosis). DESIGN: This study is composed of a prospectivedata cohortcollection studycomponent conductedand consecutivelycollaborative atprocess. Our network of over 70150 centersactive worldwideInvestigators retrospectively and/or prospectively collect data on diagnosis, etiology, treatment and outcome. ThisCollectively, cohortthey will be usedaim to develop standardized data collection forms and apply standardized proto [...] [...]
   • Minor Publications: 4 to 5
     Show what changed

     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.

   Study Status, Sponsor/Collaborators, Study Description, Outcome Measures, Eligibility, References · v31

5. May 28, 2013

   Notable

   Lead sponsor: National Institute of Neurological Disorders and Stroke (NINDS) to The Hospital for Sick Children

   Enrollment target: 1 to 12000; Primary endpoint revised; Trial status: Completed to Recruiting; and 6 more

   Show all 10 changes in this update

   • Notable Lead sponsor: National Institute of Neurological Disorders and Stroke (NINDS) to The Hospital for Sick Children
   • Notable Enrollment target: 1 to 12000
   • Notable Primary endpoint revised
     Show what changed

     ToPediatric determineStroke theoutcome dose limiting toxicities, toxicity profile, and maximum tolerated dose of CDDO when administered in adult patients with solid tumors and lymphomas.Measure
   • Minor Trial status: Completed to Recruiting
   • Minor Study sites: 2 to 1
   • Minor Primary completion date: Dec 2020
   • Minor Completion date: Sep 2011 to Dec 2020
   • Minor Secondary endpoint revised
     Show what changed

     Todischarge obtain preliminary evidence of anti-tumor activity of CDDO in this population.destination
   • Minor Study description shortened, about 9 words
     Show what changed

     [...] dy is a prospective cohort study conducted consecutively at tenover United States, United Kingdom, European, and Canadian70 centers worldwide. This cohort will be used to develop and apply standardized [...] be prospectively enrolled into a web-based data entry system, over a two-year period. OUTCOME MEASURES: This study will quantify outcome event r [...]
   • Minor Collaborators expanded, about 8 words
     Show what changed

     National Institute of Neurological Disorders and Stroke (NINDS)

   Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Outcome Measures, Eligibility, Contacts/Locations · v30

26. Jun 23, 2005

    Minor

    Study First Submitted

• Stopped: an ongoing trial was terminated, suspended or withdrawn.
• Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
• Minor: routine progress and housekeeping, such as sites added or enrollment closed.