Actively Recruiting
High Dose Steroids in Children With Stroke
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-11-18
70
Participants Needed
35
Research Sites
241 weeks
Total Duration
On this page
Sponsors
I
Insel Gruppe AG, University Hospital Bern
Lead Sponsor
U
University of Bern
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
High Dose Steroids in Children With Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent provided by the legal representative
- Age greater than 6 months and less than 18 years at stroke onset
- Randomization possible within 48 hours of diagnosis and maximum 96 hours after stroke onset
- Unilateral arteriopathy confirmed by new neurologic deficits and specific neuroimaging showing unilateral stenosis or vessel irregularities in the central nervous system
- Female participants aged 13 years or older must have a negative pregnancy test (blood or urine) unless otherwise specified in national guidelines
You will not qualify if you...
- Previous stroke
- Known syndromal disorders such as Trisomy 21 or Neurofibromatosis type 1
- Known genetic vasculopathies including posterior fossa anomalies, hemangioma, arterial, cardiac, and eye anomalies syndrome (PHACES), or ACTA II
- Moyamoya disease or sickle cell disease
- Small vessel cerebral vasculitis (primary CNS vasculitis)
- Bilateral arteriopathy
- Arterial dissection(s)
- Underlying systemic disorders like lupus or rheumatoid problems
- Secondary CNS angiitis due to infections or generalized angiitis from autoimmune causes
- Progressive large to medium childhood primary angiitis of the CNS with two of the following: pre-existing neurocognitive dysfunction, bilateral MRI lesions or vessel involvement, small vessel arterial stenosis
- Steroid treatment at disease onset
- Contraindications to steroid treatment such as congenital or acquired immunodeficiency
- Inability to follow study procedures due to language or other issues
- Participation in another interventional study within 30 days before stroke and during this study
AI-Screening
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Trial Site Locations
Total: 35 locations
1
Sydney Childrens Hospital Randwick
Randwick, New South Wales, Australia, 2031
Actively Recruiting
2
Sydney Childrens Hospital Network
Westmead, New South Wales, Australia, 2145
Actively Recruiting
3
Melbourne Childrens Hospital
Melbourne, Victoria, Australia, 3052
Actively Recruiting
4
Universitätsklinik für Pädiatrie 1 A.ö. Landeskrankenhaus/ Universitätskliniken Innsbruck
Innsbruck, Tyrol, Austria, 6020
Not Yet Recruiting
5
Johannes Kepler University Linz, Med Campus IV, Univ.-Klinik für Kinder- und Jugendheilkunde
Linz, Upper Austria, Austria, 4020
Not Yet Recruiting
6
Universitätsklinik für Kinder und Jugendheilkunde Wien
Vienna, Austria, 1090
Actively Recruiting
7
Børn og Unge - Aarhus Universitetshospital
Aarhus, Denmark, 8200
Not Yet Recruiting
8
Department of Pediatric and Adolescence Medicine Copenhagen University Hospital
Copenhagen, Denmark, 2100
Actively Recruiting
9
L'ASSISTANCE PUBLIQUE-HOPITAUX DE MARSEILLE (AP-HM) - Hôpital de la Timone
Marseille, Aix-en-Provence, France, 13005
Actively Recruiting
10
Pediatric Neurology Strasbourg - Hautepierre University Hospital
Strasbourg, Alsace, France, 67098
Actively Recruiting
11
Hôpital Femme Mère Enfant Lyon
Bron, Auvergne-Rhône-Alpes, France, 69677
Actively Recruiting
12
Hôpital Roger Salengro, CHRU de Lille
Lille, France, 59037
Actively Recruiting
13
Hôpitaux Universitaires Paris Sud
Le Kremlin-Bicêtre, Île-de-France Region, France, 94275
Actively Recruiting
14
Hôpital Necker-Enfants Malades
Paris, Île-de-France Region, France, 75743
Actively Recruiting
15
Universitätsklinikum Freiburg Zentrum für Kinder- und Jugendmedizin Klinik für Neuropädiatrie und Muskelerkrankungen
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Actively Recruiting
16
LMU Klinikum
München, Bavaria, Germany, 80337
Actively Recruiting
17
Universitätsklinikum Düsseldorf
Düsseldorf, Nordrhein-Westfahlen, Germany, 40225
Actively Recruiting
18
Universitäts Kinderklinik Münster
Münster, Nordrhein-Westfahlen, Germany, 48129
Actively Recruiting
19
Charité-Universitätsmedizin Berlin
Berlin, Germany, 13353
Actively Recruiting
20
Medizinische Hochschule Hannover OE 6720
Hanover, Germany, 30625
Actively Recruiting
21
Centrum för Kliniska Barnstudier, Astrid Lindgrens Bansjukhus, Kaolinska Universitetssjukhuset
Stockholm, Sweden, 171 76
Not Yet Recruiting
22
Centre Hôpitalier Universitaire Vaud (CHUV), Unité de Neurologie
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
23
Ospedale Regionale di Bellinzona e Valli
Bellinzona, Canton Ticino, Switzerland, 6500
Actively Recruiting
24
Kantonsspital Graubünden, Departement Kinder- und Jugendmedizin
Chur, Kanton Graubünden, Switzerland, 7000
Actively Recruiting
25
Hôpital du Valais
Sion, Valais, Switzerland, 1950
Actively Recruiting
26
Universitätskinderklinik beider Basel
Basel, Switzerland, 4056
Actively Recruiting
27
Inselspital Bern
Bern, Switzerland, 3010
Actively Recruiting
28
Hôpitale Universitaire de Genève, Neuropediatrie, Hôpital des Enfants
Geneva, Switzerland, 1211
Actively Recruiting
29
Luzerner Kantonsspital, Kinderspital, Neuropädiatrie
Lucerne, Switzerland, 6000
Active, Not Recruiting
30
Stiftung ostschweizerisches Kinderspital
Sankt Gallen, Switzerland, 9006
Actively Recruiting
31
Kidnerspital Zürich
Zurich, Switzerland, 8032
Actively Recruiting
32
Addenbrookes Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB22QQ
Actively Recruiting
33
University Hospital Southampton
Southampton, Hampshire, United Kingdom, SO166YD
Actively Recruiting
34
Royal Manchester Children's Hospital
Manchester, Lancashire, United Kingdom, M139WL
Actively Recruiting
35
University Hospital Bristol
Bristol, United Kingdom, BS13NU
Actively Recruiting
Research Team
M
Maja Steinlin, Dr. med.
CONTACT
K
Kathrin Bochud, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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