High Dose Steroids in Children With Stroke

ConditionPaediatric Stroke

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age6-17

SponsorInsel Gruppe AG, University Hospital Bern

About this trial

This clinical trial deals with focal cerebral arteriopathy and childhood stroke, a rare but devastating condition.

Focal cerebral arteriopathy (FCA) is an inflammatory vessel wall disease provoked by infection and there is increasing evidence that inflammatory processes play a crucial role in childhood stroke, influencing the outcome of the disease.

Analysis of existing data suggests that outcomes are improved and that there is less stroke recurrence in children treated with steroids to reduce the acute inflammatory processes. This clinical trial will be conducted in over 20 hospitals in several countries in order to investigate this.

Participants will be randomly separated into two groups. The first group will be treated with standard of care (including aspirin) combined with high dose steroids. The second group will be treated with standard of care (including aspirin) but without steroid treatment.

The objective is to investigate if children treated with a combination of high dose steroid and aspirin will have a better and quicker recovery of FCA, better clinical functional outcome, and less recurrence compared to children treated with aspirin alone.

This project has been identified by international pediatric stroke experts as the most important topic for a clinical trial in the field and is as well one of the most important research priorities identified by parents. The study results will also provide insight into the evolution of inflammatory vessel disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed consent of the legal representative of the trial participant documented by signature

Age > 6 months & < 18 years at time of stroke

Randomisation possible within 48 hours of diagnosis and maximum 96 hours after stroke onset

Newly acquired neurologic deficits

Disqualifiers

Previous stroke

Known syndromal disorders, as e.g. Trisomy 21, Neurofibromatosis type 1

Known genetic vasculopathies as e.g. posterior fossa anomalies, hemangioma, arterial anomalies, cardiac anomalies and eye anomalies syndrome (PHACES), actin alpha 2 (ACTA II)

Moyamoya or sickle cell disease

Trial design

Design model

Parallel

Treatments tested in this trial

Methylprednisolone
Drug
At the time of inclusion, intravenous Methylprednisolone for 3 days. Dose: 30 mg/kg/day (max. 1000 mg/dose)
Prednisolone
Drug
Intravenous treatment will be immediately followed by oral tapering with Prednisolone. Oral Prednisolone, 2 weeks (week 1 and 2) Dose: 1 mg/kg/day (max 40 mg/day) Oral Prednisolone, 2 weeks (week 3 and 4) Dose: 0.5 mg/kg/day (max 20 mg/day)

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: Steroids + Standard of careExperimental treatment 2 interventions

Group B: Standard of careNo intervention 0 interventions

Trial outcomes

Primary outcomes

Change in Focal Cerebral Arteriopathy Severity Score (FCASS) from baseline

The FCASS is a scaling system that has been developed to improve diagnostic criteria and to better document the typical course of initial worsening followed by improvement in FCA-i (focal cerebral arteriopathy of inflammatory type). FCASS Minimum score (best outcome): 0 FCASS Maximum baseline score (worst outcome): 20 FCASS Maximum follow up score (worst outcome): 21

Time frame

1 month (30 days)

Secondary outcomes

Functional impairment outcome measured by Pediatric Stroke Outcome Measure (PSOM)

The PSOM is a measure that has been specifically developed and validated for pediatric stroke patients and addresses pediatric specific domains such as development, behavior and cognition in addition to sensory-motor and language function. PSOM Minimum score (best outcome): 0 PSOM Maximum baseline score (worst outcome): 10

Time frame

1, 3, 6 and 12 months

Recovery assessed by Recovery and Recurrence Questionnaire (RRQ)

The Pediatric Recovery and Recurrence Questionnaire was specifically developed and validated for pediatric stroke patients and addresses pediatric- specific problems of manifestation of stroke and difficulties in reliable clinical examination. Minimum score (best outcome): 0 Maximum baseline score (worst outcome): 10

Time frame

1, 3, 6, and 12 months

Degree of disability or dependence by modified Rankin Scale (mRS)

Minimum score (best outcome): 0 Maximum baseline score (worst outcome): 6

Time frame

1, 3, 6, and 12 months

Clinical outcome by Vineland adaptive behavior scale (VABS)

The vineland adaptive behavior scale is a validated instrument to monitor cognitive and behavior problems of children by interview. (range=40-160, the higher the score the better the performance)

Time frame

6 and 12 months