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

Completed

• Conditions: Cerebral Infarction

• Registration Number: NCT02511249
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2015-07
• Study First Submitted: 2015-07-24
• Study First Submitted QC: 2015-07-29
• Last Update Submitted: 2015-07-29
• Study First Posted: 2015-07-30
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Belonging to the AVCnn cohort

Exclusion Criteria

• Lost to follow-up at 7 years.
• Refusal to participate in the current assessment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epileptic outcome	at 7 years	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
Academic outcome (composite measure)	at 7 years	Grade retention or the need for specific and individualized support in mainstream school or inclusion in a special school.
Neurodevelopmental outcome at 7 years	at 7 years	permanent abnormal tone or decreased strength associated with a patent functional deficit

Secondary Outcome Measures

Name	Time	Method
Cerebral imaging ancillary study	at 7 years	Anatomic post-lesional connectivity.

Trial Locations

Locations (5)

Chu D'Angers; 🇫🇷 Angers, France

Chu de Saint Etienne; 🇫🇷 Saint Etienne, France

Chu de Brest; 🇫🇷 Brest, France

Centre Hospitalier de La Cote Basque; 🇫🇷 Bayonne, France

Hopital Necker; 🇫🇷 Paris, France