Early Determinants of Multidimensional Outcome at School Age After Neonatal Arterial Ischemic Stroke

Study Overview
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Brief Summary
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While perinatal ischemic stroke is the most frequent form of childhood stroke, early determinants of outcome remain poorly understood. Two main structural biases limit the accuracy of most studies: heterogeneity of the population and short follow-up. Perinatal ischemic stroke includes several conditions that differ in pathophysiology and timing of occurrence. Yet, it is not surprising that risk factors and outcome depend primarily on the type of stroke. Age at evaluation also plays a major role after a neonatal insult. Even though the original lesion is static and focal in perinatal stroke, its consequences grow over time within the maturing brain and affect all fields of neurodevelopment. The objective of the AVCnn study was to delineate the determinants, clinical and imaging presentation, mechanism, and long term outcome of a category of perinatal stroke (neonatal arterial ischemic stroke: NAIS). This led to the AVCnn cohort, which now gives us the opportunity to regularly monitor a large cohort of children having suffered an NAIS.

Detailed Description
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Between November 2003 and October 2006, a cohort of one hundred symptomatic term newborns with AIS confirmed through early brain imaging has been constituted. Regular contacts with the families and their local physician have been maintained since enrollment. In 2010, families were asked through postal mail to participate in the 7 years assessment (AVCnn7ans). Those who accepted were contacted by phone by the coordinators of the study during the months preceding the child's seventh birthday and invited to attend a presentation in person of the current project. This evaluation took place face-to-face for a whole day in a medical setting close to the family residence. The evaluation team included a neuropsychologist, a speech therapist and either a pediatric neurologist or a pediatric physical and rehabilitation medicine practitioner.

Official Title
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Early Determinants of Multidimensional Outcome at School Age After Neonatal Arterial Ischemic Stroke (AVCnn7 Years Study)

Conditions
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Cerebral Infarction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Belonging to the AVCnn cohort Exclusion Criteria: Lost to follow-up at 7 years. Refusal to participate in the current assessment.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cohort<br>1 evaluation day : The evaluation team included a neuropsychologist, a speech therapist and either a pediatric neurologist or a pediatric physical and rehabilitation medicine practitioner. tests carried out : Global intellectual functioning (WISC-IV), Oral language (N-EEL), Gross and fine motor abilities (clinical examination, Box & Block test, 9 Hole Peg test) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epileptic outcome | Occurrence of two or more afebrile unprovoked seizures after the neonatal period or, in the event of single afebrile unprovoked seizure, when it was decided to introduce antiepileptic treatment | at 7 years | 
| Academic outcome (composite measure) | Grade retention or the need for specific and individualized support in mainstream school or inclusion in a special school. | at 7 years | 
| Neurodevelopmental outcome at 7 years | permanent abnormal tone or decreased strength associated with a patent functional deficit | at 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral imaging ancillary study | Anatomic post-lesional connectivity. | at 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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motor abilities, neonatal arterial ischemic stroke, language development, global intellectual functioning