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

July 29, 2015 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • CHU d'Angers
      • Bayonne, France, 64100
        • Centre Hospitalier de La Cote Basque
      • Brest, France, 29609
        • Chu de Brest
      • Paris, France, 75015
        • Hopital Necker
      • Saint Etienne, France, 42055
        • Chu de Saint Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study 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

Description

Inclusion Criteria:

  • Belonging to the AVCnn cohort

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
cohort

1 evaluation day : The evaluation team included a neuropsychologist, a speech therapist and either a pediatric neurologist or a pediatric physical and rehabilitation medicine practitioner.

tests carried out : Global intellectual functioning (WISC-IV), Oral language (N-EEL), Gross and fine motor abilities (clinical examination, Box & Block test, 9 Hole Peg test)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 7 years
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.
at 7 years
Neurodevelopmental outcome at 7 years
Time Frame: at 7 years
permanent abnormal tone or decreased strength associated with a patent functional deficit
at 7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral imaging ancillary study
Time Frame: at 7 years
Anatomic post-lesional connectivity.
at 7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

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

Investigators

  • Principal Investigator: Stéphane CHABRIER, MD, Centre Hospitalier Universitaire de Saint Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

July 24, 2015

First Submitted That Met QC Criteria

July 29, 2015

First Posted (Estimate)

July 30, 2015

Study Record Updates

Last Update Posted (Estimate)

July 30, 2015

Last Update Submitted That Met QC Criteria

July 29, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1008026
  • ANSM (Other Identifier: 2025-A02337-42)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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