High Dose Steroids in Children With Stroke
This study is investigating a specific type of stroke in children called focal cerebral arteriopathy (FCA). This condition causes inflammation in the blood vessels of the brain. Experts believe this inflammation plays a key role in how well children recover from a stroke. The study aims to see if adding strong anti-inflammatory medicines, called steroids, to the usual treatment (which includes aspirin) can improve recovery. Children involved will be split into two groups: one receiving steroids plus standard care, and the other receiving standard care only. The goal is to find out if steroids help children recover faster, experience fewer problems after their stroke, and reduce the chance of another stroke. This research is seen as vital by both medical experts and parents of children affected by stroke.
At a glance
What is this study about?
This study explores a type of stroke in children called focal cerebral arteriopathy (FCA). This is a rare, but serious, condition where the blood vessels in the brain become inflamed. Doctors believe that infections can sometimes trigger this inflammation, and that this inflammation significantly affects how well a child recovers from a stroke. While steroids are known to reduce inflammation, we don't yet have strong evidence in children with FCA.
This research is important because childhood stroke can unfortunately lead to long-term difficulties with movement, learning, and behaviour. By understanding if steroids can help reduce inflammation and improve outcomes, doctors hope to find a better way to treat children who have experienced this kind of stroke. This study has been highlighted by stroke experts and parents as a top priority for research in this area.
To find the answers, doctors in over 20 hospitals across different countries will be working together. Children taking part will be divided randomly into two groups. One group will receive the usual care, including a medicine called aspirin, along with a high dose of steroids. The other group will receive the usual care with aspirin, but without steroids. This will help doctors compare the two approaches and see if adding steroids makes a real difference in a child's recovery, how quickly they get better, and if it helps prevent future strokes.
Key takeaways
- New study for children aged 6 months to 17 years who recently had a stroke.
- Investigating if steroids help children recover better from a specific stroke type.
- Children will be randomly assigned to receive steroids or not, alongside standard care.
- A major international effort, prioritised by experts and parents.
- Aims for better, quicker recovery and fewer future strokes.
- Participation involves medication and regular check-ups.
Who may be eligible?
Children who might be able to join this study are typically between 6 months and 17 years old at the time of their stroke. They must have been diagnosed with a specific type of stroke called unilateral focal cerebral arteriopathy (FCA), which involves inflammation in the blood vessels on one side of the brain. Doctors will need to confirm this diagnosis using special brain scans, and the child must be able to start the study treatment within a few days of their stroke.
However, some children will not be able to participate. This includes children who have had a stroke before, or those with certain known medical conditions like genetic disorders (for example, Down syndrome or Neurofibromatosis type 1), or other types of blood vessel problems in the brain. Children who are already taking steroids when their stroke happens, or who have reasons they cannot take steroids due to other health issues (like a weak immune system), also won't be able to join. The study also cannot include children who are already participating in another trial involving new treatments.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is your child between 6 months and 17 years old?
- Did their stroke happen recently (within the last few days)?
- Has your child been diagnosed with focal cerebral arteriopathy (FCA) on one side of the brain?
- Has your child never had a stroke before?
- Does your child not have other serious long-term conditions or genetic disorders?
- Can your child take steroids without any specific health risks?
What does participation involve?
If your child takes part in this study, they will either receive the usual care for a stroke (including aspirin) along with a high dose of steroids, or they will receive the usual care without steroids. The treatment portion of the study will involve giving medication. Your child will have regular check-ups and assessments by the study team. These visits will likely include physical examinations and possibly further brain scans to see how the blood vessels are recovering and how well your child is doing. The study will follow your child's progress for a set period, to understand the long-term effects of the treatment. The total duration of participation and follow-up will be explained in detail by the study team.
Potential risks and benefits
Locations (35)
- Sydney Childrens Hospital RandwickVerified postcodeRandwick, Australia· Recruiting
- Sydney Childrens Hospital NetworkVerified postcodeWestmead, Australia· Recruiting
- Melbourne Childrens HospitalVerified postcodeMelbourne, Australia· Recruiting
- Universitätsklinik für Pädiatrie 1 A.ö. Landeskrankenhaus/ Universitätskliniken InnsbruckVerified postcodeInnsbruck, Austria· Not yet recruiting
- Johannes Kepler University Linz, Med Campus IV, Univ.-Klinik für Kinder- und JugendheilkundeVerified postcodeLinz, Austria· Not yet recruiting
- Universitätsklinik für Kinder und Jugendheilkunde WienVerified postcodeVienna, Austria· Recruiting
- Børn og Unge - Aarhus UniversitetshospitalVerified postcodeAarhus, Denmark· Not yet recruiting
- Department of Pediatric and Adolescence Medicine Copenhagen University HospitalVerified postcodeCopenhagen, Denmark· Recruiting
- L'ASSISTANCE PUBLIQUE-HOPITAUX DE MARSEILLE (AP-HM) - Hôpital de la TimoneVerified postcodeMarseille, France· Recruiting
- Pediatric Neurology Strasbourg - Hautepierre University HospitalVerified postcodeStrasbourg, France· Recruiting
- Hôpital Femme Mère Enfant LyonVerified postcodeBron, France· Recruiting
- Hôpital Roger Salengro, CHRU de LilleVerified postcodeLille, France· Recruiting
Common questions
What is focal cerebral arteriopathy (FCA)?
FCA is a type of stroke in children where blood vessels in the brain become inflamed, often triggered by an infection.
Why are you studying steroids for stroke?
Steroids are strong anti-inflammatory medicines. We want to see if reducing inflammation in the brain with steroids can help children recover better from this type of stroke.
Will my child definitely get steroids?
No, children in the study will be randomly put into one of two groups: one receiving steroids plus standard care, and one receiving standard care only.
Is this study safe for my child?
All treatments have potential risks and benefits. The study team will explain these in detail so you can make an informed decision for your child.
How long will my child be in the study?
The study involves treatment and follow-up over a period of time, which the study team will explain to you in full detail.
How to find out more
Maja Steinlin, Dr. med.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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