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

Cerebral Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02511249
• Other study ID #: 1008026
• Secondary ID: ANSM
• Status: Completed
• Phase: N/A
• First received: July 24, 2015
• Last updated: July 29, 2015
• Start date: October 2010
• Est. completion date: November 2013

Study information

• Verified date: July 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 7 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Infarction

Locations

Country	Name	City	State
France	Chu D'Angers	Angers
France	Centre Hospitalier de La Cote Basque	Bayonne
France	Chu de Brest	Brest
France	Hopital Necker	Paris
France	Chu de Saint Etienne	Saint Etienne

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry for Health and Solidarity, France, University Hospital of Saint-Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Neurodevelopmental outcome at 7 years	permanent abnormal tone or decreased strength associated with a patent functional deficit	at 7 years	No
Secondary	Cerebral imaging ancillary study	Anatomic post-lesional connectivity.	at 7 years	No