Clinical trial NCT02511249: Early Determinants of Multidimensional Outcome at School Age After Neonatal Arterial Ischemic Stroke
Official title: Early Determinants of Multidimensional Outcome at School Age After Neonatal Arterial Ischemic Stroke (AVCnn7 Years Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Infarction
Keywords: neonatal arterial ischemic stroke
language development
global intellectual functioning
motor abilities
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry for Health and Solidarity, France
name: University Hospital of Saint-Etienne
First posted: 2015-07-30
Enrollment: 80
Sex: ALL
Minimum age (years): 7
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Belonging to the AVCnn cohort

Exclusion Criteria:

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

Primary outcomes:
measure: Epileptic outcome
timeFrame: at 7 years
measure: Academic outcome (composite measure)
timeFrame: at 7 years
measure: Neurodevelopmental outcome at 7 years
timeFrame: at 7 years
Secondary outcomes:
measure: Cerebral imaging ancillary study
timeFrame: at 7 years
Other outcomes:
Locations:
city: Angers
country: France
facility: Chu D'Angers
city: Bayonne
country: France
facility: Centre Hospitalier de La Cote Basque
city: Brest
country: France
facility: Chu de Brest
city: Paris
country: France
facility: Hopital Necker
city: Saint Etienne
country: France
facility: Chu de Saint Etienne
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: Stéphane CHABRIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.