Arterial ischemic stroke (AIS) is a devastating condition, affecting 1.6-5/100,000 children/year. Although their outcome is different, children with stroke do not recover better than adults, with at least 2/3 suffering long term sequels such as developmental (motor, global intellectual, language...) and behavioral disabilities, epilepsy, and low adaptative and academic skills... Stenotic cerebral arteriopathy is identified as AIS etiology in 60-80% of previously healthy children and the course of this arteriopathy is the strongest predictor of recurrent events. 30-40% of these children have a focal unilateral cerebral arteriopathy (FCA). Childhood FCA is suspected to be an inflammatory vessel wall pathology triggered by varicella and other (viral) infections. As recurrences occur for the great majority in the first 6 months after the index event, aspirin 5 mg/kg/day is recommended for at least 18 months to 2 years. As there is a rational for using immunomodulatory drugs at the acute stage of FCA, immunotherapies are currently used by neuropaediatricians in AIS, mainly as steroids for children with stenosing arteriopathies. However, due to weak evidences, the literature cannot either encourage or discourage this practice. The long term course of children with FCA is only approach to date by retrospective studies and controversies about outcome remain (for example, the recurrence risk on antithrombotic treatment varies notably from quasi zero to 25%). And finally, it is shown in childhood stroke, as well as in the global field of longstanding impairment, that parental and medical points of view do not match consistently. Longitudinal studies are needed to deserve this familial approach.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
The experimental intervention consists of 5 consecutive days Methylprednisolone at a daily single intravenous dose of 20 mg/kg body-weight (max 1 g/day) followed by a 4-week course of tapering Prednisolone given at a daily single oral dose in the morning: * week 1 and 2, oral Prednisolone 1 mg/kg/day (max 40 mg/day), , * week 3 and 4, oral Prednisolone 0,5 mg/kg/day (max 20 mg/day),
Time to recovery up to 12 months
Evaluate of time to recovery up to 12 months by score paediatric Recurrence and Recovery Questionnaire (RRQ )
Time frame: Up to 12 months
Improvement of functional outcome by face-to-face visits
Evaluate of Improvement of functional outcome by face-to-face visits by score Paediatric Stroke Outcome Measure (PSOM), modified Rankin Scale (mRS) and Vineland Adaptive Behaviour Scale (VABS).
Time frame: Months:1,6,12, 24 and 36
Arteriopathic course along time
Evaluate of Arteriopathic course along time by comparison between magnetic resonance (MR) arteriography and initial imaging.
Time frame: Months: 1, 6, 24
Recurrence of stroke, epilepsy, neurological and developmental sequels, and academic achievement
Evaluate recurrence of stroke, epilepsy, neurological and developmental sequels, and academic achievement at 6, 12, 24 and 36 months. Neurological outcome will be assessed by standard clinical examination: motricity, sensibility, coordination, oculomotricity and visual field, cranial nerves…
Time frame: Months: 1, 3, 6,12, 24 and 36
Outcome by age group
Evaluate outcome by age group. All endpoints will be stratified for the whole cohort by the following age group: 0.5-3 years; 3-6 years; 6-10 years and ≥10 years. This will be done in a centrally-manner at Clinical Trials Unit (CTU) Bern.
Time frame: Months 72
Familial impact
Evaluate of familial impact by Alberta Perinatal Stroke Parental Outcome Measure (APSOM) and indepth interview through semi-structured interviews. The objective is to report the lived experience of parents whose child was included in the study.
Time frame: Months 72
Number of serious adverse events
Analysis of number of serious adverse events and their cause, consequence.
Time frame: Months 72
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