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

NCT02511249 | Completed

• 2 other identifiers: 1008026ANSM
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 5

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.

Conditions

Cerebral Infarction

Keywords

neonatal arterial ischemic stroke; language development; global intellectual functioning; motor abilities

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Neurodevelopmental outcome at 7 years

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

  at 7 years

Secondary Outcomes (1)

• Cerebral imaging ancillary study

  at 7 years

Study Arms (1)

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)

Eligibility Criteria

• Age: 7 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• Belonging to the AVCnn cohort

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Ministry for Health and Solidarity, France: collaborator
• University Hospital of Saint-Etienne: collaborator

Study Sites (5)

Chu D'Angers

Angers, 49933, France

Location

Centre Hospitalier de La Cote Basque

Bayonne, 64100, France

Location

Chu de Brest

Brest, 29609, France

Location

Hopital Necker

Paris, 75015, France

Location

Chu de Saint Etienne

Saint-Etienne, 42055, France

Location

Related Publications (5)

• 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.

  PMID: 29624666 DERIVED

• 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.

  PMID: 28893386 DERIVED

• 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.

  PMID: 28815625 DERIVED

• 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.

  PMID: 27165960 DERIVED

• 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.

  PMID: 26968833 DERIVED

MeSH Terms

Conditions

Cerebral Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

• Stéphane CHABRIER, MD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2015
• First Posted: July 30, 2015
• Study Start: October 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: July 30, 2015

Record last verified: 2015-07

Locations

FR (5)