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

Completed

Phase N/A Results N/A

Trial Description

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

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.

Conditions

Trial Design

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

Trial Population

Children who have had an ischemic arterial stroke between November 2003 and October 2006, in France, who was included in "AVCnn cohort" and who accept an psychological and physical examination at 7 years

Outcomes

Type Measure Time Frame Safety Issue
Primary Epileptic outcome at 7 years No
Primary Academic outcome (composite measure) at 7 years No
Primary Neurodevelopmental outcome at 7 years at 7 years No
Secondary Cerebral imaging ancillary study at 7 years No

Sponsors