Early Determinants of Multidimensional Outcome at School Age After Neonatal Arterial Ischemic Stroke
NCT ID: NCT02511249
Last Updated: 2015-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2010-10-31
2013-11-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Refusal to participate in the current assessment.
7 Years
7 Years
ALL
No
Sponsors
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Ministry for Health and Solidarity, France
OTHER_GOV
University Hospital of Saint-Etienne
OTHER
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Stéphane CHABRIER, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Saint Etienne
Locations
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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, , France
Countries
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References
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Thebault G, Martin S, Brouillet D, Brunel L, Dinomais M, Presles E, Fluss J, Chabrier S; AVCnn Study Group. Manual dexterity, but not cerebral palsy, predicts cognitive functioning after neonatal stroke. Dev Med Child Neurol. 2018 Oct;60(10):1045-1051. doi: 10.1111/dmcn.13752. Epub 2018 Apr 6.
Dinomais M, Thebault G, Hertz-Pannier L, Gautheron V, Nguyen The Tich S, Fluss J, Chabrier S; AVCnn Study Group. Is there an excess of left-handedness after neonatal stroke? Cortex. 2017 Nov;96:161-164. doi: 10.1016/j.cortex.2017.08.007. Epub 2017 Aug 16. No abstract available.
Groeschel S, Hertz-Pannier L, Delion M, Loustau S, Husson B, Kossorotoff M, Renaud C, Nguyen The Tich S, Chabrier S, Dinomais M; AVCnn study group. Association of transcallosal motor fibres with function of both hands after unilateral neonatal arterial ischemic stroke. Dev Med Child Neurol. 2017 Oct;59(10):1042-1048. doi: 10.1111/dmcn.13517. Epub 2017 Aug 17.
Dinomais M, Hertz-Pannier L, Groeschel S, Delion M, Husson B, Kossorotoff M, Renaud C, Chabrier S, The Tich SN; AVCnn Study Group. Does Contralesional Hand Function After Neonatal Stroke Only Depend on Lesion Characteristics? Stroke. 2016 Jun;47(6):1647-50. doi: 10.1161/STROKEAHA.116.013545. Epub 2016 May 10.
Chabrier S, Peyric E, Drutel L, Deron J, Kossorotoff M, Dinomais M, Lazaro L, Lefranc J, Thebault G, Dray G, Fluss J, Renaud C, Nguyen The Tich S; Accident Vasculaire Cerebral du nouveau-ne (AVCnn; [Neonatal Stroke]) Study Group. Multimodal Outcome at 7 Years of Age after Neonatal Arterial Ischemic Stroke. J Pediatr. 2016 May;172:156-161.e3. doi: 10.1016/j.jpeds.2016.01.069. Epub 2016 Mar 9.
Other Identifiers
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ANSM
Identifier Type: OTHER
Identifier Source: secondary_id
1008026
Identifier Type: -
Identifier Source: org_study_id
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