Database for Stroke in Infants and Children
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|ClinicalTrials.gov Identifier: NCT00084292|
Recruitment Status : Recruiting
First Posted : June 10, 2004
Last Update Posted : June 26, 2017
This multi-center collaborative study will establish a database of information about stroke in infants and children.
Participating children have their medical and research records reviewed for information about their stroke. The information is gathered and entered into a secure electronic database called REDCap. All information is de-identified.
This study does not require any additional interventions but two outcome measures are typically administered: the Paediatric Stroke Outcome Measure (PSOM) and the Recovery and Recurrence Questionnaire (RRQ). The PSOM is used during clinic visits by the study co-investigator; the RRQ is a parental questionnaire that can be completed during clinic visits or by telephone interview for those parents who cannot attend the follow up appointment. Both measures assess neurological function.
The IPSS also provides participating centers with the option to share de-identified patient CT and MRI's in the IPSS Imaging Repository housed at The Hospital for Sick Children in Toronto, Canada; incorporating a neuroimaging component would improve our understanding of the processes underlying plasticity and recovery in childhood stroke.
Participating Investigators have the opportunity to access the larger dataset for use in group publications but each center will retain ownership of their own data. These contributing Investigators are recognized through authorship.
The activities of the network are creating the opportunity for manuscript writing, grant development and collaboration on clinical challenges in paediatric stroke. Ultimately, this data will allow physicians to better diagnose, treat, and prevent stroke in children.
|Condition or disease|
OBJECTIVES: This is the first multi-center, multi-national study of children with stroke. It seeks to build a network of investigators and baseline disease data to enable childhood stroke clinical trials to be developed.
STUDY POPULATION: Infants and children with ischemic stroke (arterial ischemic stroke and sinovenous thrombosis).
DESIGN: This study is composed of a data collection component and collaborative process. Our network of over 150 active Investigators retrospectively and/or prospectively collect data on diagnosis, etiology, treatment and outcome. Collectively, they aim to develop standardized data collection forms and protocols for neonates and children with arterial ischemic stroke (AIS) and cerebral sinovenous thrombosis (CSVT).
Children with diagnosis of stroke made after January 2003, will be prospectively enrolled into a web-based data entry system.
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. Some predictor testing for outcomes within strata may be utilized for web-based data.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||12000 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||International Pediatric Stroke Study|
|Study Start Date :||January 2003|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
- 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.
- 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) to a questionnaire for patient/parent telephone interview. The agreement and consistency of the PSOM and RRQ is then assessed, and identified conditions that contributed to differences between the 2 measures
- Discharge destination [ Time Frame: At discharge ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00084292
|Contact: IPSS Cofirstname.lastname@example.org|
|Hospital For Sick Children||Recruiting|
|Toronto, Ontario, Canada|
|Contact: IPSS Co-ordinator email@example.com|