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NCT Number: NCT02511249

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

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.

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Key information

Conditions

Cerebral Infarction Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infarction Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

7 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu D'Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Belonging to the AVCnn cohort

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Epileptic outcome

    Time frame: 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

  2. Academic outcome (composite measure)

    Time frame: at 7 years

    Grade retention or the need for specific and individualized support in mainstream school or inclusion in a special school.

  3. Neurodevelopmental outcome at 7 years

    Time frame: at 7 years

    permanent abnormal tone or decreased strength associated with a patent functional deficit

Secondary outcomes

  1. Cerebral imaging ancillary study

    Time frame: at 7 years

    Anatomic post-lesional connectivity.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Ministry for Health and Solidarity, France
  • University Hospital of Saint-Etienne

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 30, 2015
Registry last updated
Jul 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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