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

Официальное название

International Pediatric Stroke Study

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Change from Pediatric Stroke Outcome Measure at 3 months. [Срок оценки: 3-12 months post-stroke]
• Recovery and Recurrence Questionnaire [Срок оценки: 3-12 months post-stroke]
• King's Outcome Scale for Childhood Head Injury (KOSCHI) [Срок оценки: 3-12 months post-stroke]
• modified Rankin Scale (mRS) [Срок оценки: 3-12 months post-stroke]

Вторичные конечные точки (1)

• Investigator-Initiated Research Studies [Срок оценки: As proposed]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Канада · 1 центр

• Hospital For Sick Children — Toronto

Публикации

• 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
• 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
• 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
• 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
• Sun LR, Linds A, Sharma M, Rafay M, Vadivelu S, Lee S, Brandao LR, Appavu B, Estepp JH, Hukin J, Hassanein SMA, Chan A, Beslow LA; International Pediatric Stroke Study Group. Cancer and Tumor-Associated Childhood Stroke: Results From the International Pediatric Stroke Study. Pediatr Neurol. 2020 Oct;111:59-65. doi: 10.1016/j.pediatrneurol.2020.06.002. Epub 2020 Jun 10. PMID 32951663

Идентификаторы

NCT: NCT00084292 · 1000070460 · 04-N-0210 · 1000070460

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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