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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


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
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