Clinical Research Directory
Browse clinical research sites, groups, and studies.
High Dose Steroids in Children With Stroke
Sponsor: Insel Gruppe AG, University Hospital Bern
Summary
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.
Official title: High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy: A Multicentre Randomized Controlled Trial PASTA (Paediatric Arteriopathy Steroid Aspirin) Trial
Key Details
Gender
All
Age Range
6 Months - 17 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2021-11-16
Completion Date
2026-07
Last Updated
2025-11-18
Healthy Volunteers
No
Conditions
Interventions
Methylprednisolone
At the time of inclusion, intravenous Methylprednisolone for 3 days. Dose: 30 mg/kg/day (max. 1000 mg/dose)
Prednisolone
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)
Locations (35)
Sydney Childrens Hospital Randwick
Randwick, New South Wales, Australia
Sydney Childrens Hospital Network
Westmead, New South Wales, Australia
Melbourne Childrens Hospital
Melbourne, Victoria, Australia
Universitätsklinik für Pädiatrie 1 A.ö. Landeskrankenhaus/ Universitätskliniken Innsbruck
Innsbruck, Tyrol, Austria
Johannes Kepler University Linz, Med Campus IV, Univ.-Klinik für Kinder- und Jugendheilkunde
Linz, Upper Austria, Austria
Universitätsklinik für Kinder und Jugendheilkunde Wien
Vienna, Austria
Børn og Unge - Aarhus Universitetshospital
Aarhus, Denmark
Department of Pediatric and Adolescence Medicine Copenhagen University Hospital
Copenhagen, Denmark
L'ASSISTANCE PUBLIQUE-HOPITAUX DE MARSEILLE (AP-HM) - Hôpital de la Timone
Marseille, Aix-en-Provence, France
Pediatric Neurology Strasbourg - Hautepierre University Hospital
Strasbourg, Alsace, France
Hôpital Femme Mère Enfant Lyon
Bron, Auvergne-Rhône-Alpes, France
Hôpital Roger Salengro, CHRU de Lille
Lille, France
Hôpitaux Universitaires Paris Sud
Le Kremlin-Bicêtre, Île-de-France Region, France
Hôpital Necker-Enfants Malades
Paris, Île-de-France Region, France
Universitätsklinikum Freiburg Zentrum für Kinder- und Jugendmedizin Klinik für Neuropädiatrie und Muskelerkrankungen
Freiburg im Breisgau, Baden-Wurttemberg, Germany
LMU Klinikum
München, Bavaria, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Nordrhein-Westfahlen, Germany
Universitäts Kinderklinik Münster
Münster, Nordrhein-Westfahlen, Germany
Charité-Universitätsmedizin Berlin
Berlin, Germany
Medizinische Hochschule Hannover OE 6720
Hanover, Germany
Centrum för Kliniska Barnstudier, Astrid Lindgrens Bansjukhus, Kaolinska Universitetssjukhuset
Stockholm, Sweden
Centre Hôpitalier Universitaire Vaud (CHUV), Unité de Neurologie
Lausanne, Canton of Vaud, Switzerland
Ospedale Regionale di Bellinzona e Valli
Bellinzona, Canton Ticino, Switzerland
Kantonsspital Graubünden, Departement Kinder- und Jugendmedizin
Chur, Kanton Graubünden, Switzerland
Hôpital du Valais
Sion, Valais, Switzerland
Universitätskinderklinik beider Basel
Basel, Switzerland
Inselspital Bern
Bern, Switzerland
Hôpitale Universitaire de Genève, Neuropediatrie, Hôpital des Enfants
Geneva, Switzerland
Luzerner Kantonsspital, Kinderspital, Neuropädiatrie
Lucerne, Switzerland
Stiftung ostschweizerisches Kinderspital
Sankt Gallen, Switzerland
Kidnerspital Zürich
Zurich, Switzerland
Addenbrookes Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
University Hospital Southampton
Southampton, Hampshire, United Kingdom
Royal Manchester Children's Hospital
Manchester, Lancashire, United Kingdom
University Hospital Bristol
Bristol, United Kingdom