Database for Stroke in Infants and Children

Recruiting

Phase N/A Results N/A

Trial Description

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.

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 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.

Conditions

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial Population

neonates and children with arterial ischemic stroke and cerebral sinovenous thrombosis

Outcomes

Type Measure Time Frame Safety Issue
Primary Pediatric Stroke outcome Measure 3 and 12 months post-stroke No
Secondary discharge destination at discharge No
Primary Change from Pediatric Stroke Outcome Measure at 3 months 3 & 12 months post-stroke
Primary Recovery and Recurrence Questionnaire 3 & 12 months post-stroke

Sponsors