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Database for Stroke in Infants and Children

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Gabrielle deVeber, The Hospital for Sick Children
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Gabrielle deVeber, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00084292
First received: June 9, 2004
Last updated: June 22, 2017
Last verified: June 2017
  Purpose

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
Cerebrovascular Accident

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: International Pediatric Stroke Study

Resource links provided by NLM:


Further study details as provided by Gabrielle deVeber, The Hospital for Sick Children:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Discharge destination [ Time Frame: At discharge ]

Estimated Enrollment: 12000
Study Start Date: January 2003
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
neonates and children with arterial ischemic stroke and cerebral sinovenous thrombosis
Criteria

Inclusion Criteria:

• A 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 diagnosed after January 1st, 2003
  • Must have both clinical and radiological evidence present

    1. 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.
    2. Neonates: seizures or lethargy alone may be the only acute symptom AND CT or MRI showing infarct.
    3. Haemorrhagic infarction (ischemic infarct with secondary haemorrhage)
    4. Hypoxic ischemic event with diffuse or bilateral infarction, if there is in addition a definite focal, single arterial infarct in a specified vascular territory. (e.g. middle cerebral artery, or MCA, mentioned in the radiographic report.)

CSVT

  • Age: birth (premature infants included) to 18 years of age
  • Event diagnosed after January 1st, 2003
  • Must have both clinical and radiological evidence present

    1. Clinical criteria: any transient neurological dysfunction including

      • headache, seizure, decreased level of consciousness
      • focal neurological signs consistent with CSVT
    2. Neuroimaging criteria: thrombosis of cerebral veins or venous sinuses seen on MRI, MR venography, CT venography

Note: for older infants and children CT alone if definite is acceptable, but not for neonates under 1 month of age.

Cerebrovascular condition other than CSVT/AIS

  1. Presumed pre/perinatal ischemic stroke (PPIS): infants and children whose stroke is presumed to have occurred in the prenatal or perinatal period. These patients have a normal developmental history up until about 4-8 months of age, when they present with early hand preference or hemiparesis. Neuroimaging shows an old infarct.
  2. IPSS only apply the term TIA (Transient Ischemic Attack) to transitory (less than 24 hours) neurological deficit of vascular origin with no visible (new) infarct on neuroimaging.
  3. Arteritis, vasculitis, vasculopathy, moya-moya with no clinical events or TIA only

Exclusion Criteria

• A patient who meets any of the following criteria will not be eligible for the study:

  1. Cerebral haemorrhage not associated with ischemic infarct.
  2. Hypoxic ischemic event with diffuse or bilateral infarction alone (not associated with one of the above conditions).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084292

Contacts
Contact: IPSS Co-ordinator ipss.research@sickkids.ca

Locations
Canada, Ontario
Hospital For Sick Children Recruiting
Toronto, Ontario, Canada
Contact: IPSS Co-ordinator       ipss.research@sickkids.ca   
Sponsors and Collaborators
The Hospital for Sick Children
National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Publications:
Responsible Party: Gabrielle deVeber, Senior scientist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00084292     History of Changes
Other Study ID Numbers: 0019920593
04-N-0210
Study First Received: June 9, 2004
Last Updated: June 22, 2017

Keywords provided by Gabrielle deVeber, The Hospital for Sick Children:
Ischemia
Pediatric
Etiology
Treatment
Outcome
Childhood Stroke
Pediatric Stroke
Ischemic Stroke
Spastic Hemiplegia
Hemiplegic cerebral palsy

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 27, 2017