CompletedInterventional

Corticosteroids plus standard of care treatment versus standard of care treatment alone to prevent heart complications in Kawasaki disease

Kawasaki disease is a rare condition that causes blood vessels across the body to become swollen and inflamed. It is particularly dangerous when it affects the arteries supplying blood to the heart. The usual treatment is aspirin alongside a drip of antibodies called IVIG. However, around one in five children in the UK still develop heart problems despite this treatment. This trial is looking to see if adding a steroid medicine called prednisolone to the usual care can better prevent heart damage. Children aged between 30 days and 15 years who have Kawasaki disease can take part. Half the patients will receive standard care, and half will receive standard care plus steroid medicine for two to three weeks. Doctors will track their heart health using painless ultrasound scans over 12 weeks to see which treatment works best.

At a glance

Status

Completed

Sponsor

University College London

Enrolment target

262

Start

01 Sep 2020

Estimated completion

31 Jul 2024

Coronary artery aneurysms in Kawasaki disease

What is this study about?

Kawasaki disease is an illness that mainly affects young children. It causes blood vessels throughout the body to become inflamed and swollen. While the exact cause is still unknown, doctors know that early treatment is vital. Without quick treatment, the swelling can weaken the coronary arteries—the blood vessels that feed the heart—causing lasting damage or bulging known as aneurysms.

The current standard treatment involves an infusion of healthy donor antibodies (called IVIG) and aspirin to quickly reduce inflammation. Although this treatment helps most young patients, about 19% of children with Kawasaki disease in the UK still experience heart damage. Doctors are urgently searching for ways to improve this outcome and prevent long-term heart trouble.

This study, called KD-CAAP, tests whether giving a well-known anti-inflammatory medicine called prednisolone (a corticosteroid) alongside the usual IVIG and aspirin gives extra protection. Steroids have been used safely for decades to calm the immune system in other conditions. By comparing children who receive steroids with those who receive standard treatment alone, researchers hope to discover the safest, most effective way to protect children's hearts.

Key takeaways

The trial looks at whether adding a steroid medicine to standard care prevents heart damage in Kawasaki disease.
Open to children and young people aged 30 days to 15 years diagnosed with Kawasaki disease.
All participants receive the standard care of IVIG antibodies and aspirin.
Half of the participants also receive the steroid prednisolone for two to three weeks.
Follow-up lasts 12 weeks and includes painless heart ultrasound scans.
Participation is voluntary and standard medical care is guaranteed throughout.

Who may be eligible?

This trial is open to babies, children, and young people aged between 30 days and 15 years old who have been diagnosed with Kawasaki disease.

A doctor diagnoses Kawasaki disease based on specific symptoms. These include a high fever lasting five days or more, combined with signs such as a rash, bloodshot eyes, swollen neck glands, red cracked lips or a 'strawberry' tongue, and redness or peeling on the hands and feet. Children with 'incomplete' Kawasaki disease—meaning they have a fever and some, but not all, of these symptoms alongside unusual blood tests—may also be eligible.

Parents or legal guardians must give written permission for their child to join. Older children and teenagers will also be asked if they agree to take part.

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.

My child is aged between 30 days and 15 years old.
My child has been diagnosed with Kawasaki disease (or suspected incomplete Kawasaki disease).
My child has had a high fever alongside other symptoms like a rash, red eyes, swollen neck glands, or red lips and tongue.
My child is ready to start treatment at a participating hospital.
I am the parent or legal guardian and can provide written consent.

Answer every question to see your result.

What does participation involve?

If your child joins the study, a computer will place them into one of two groups by chance (randomly). Both groups receive the full standard care of IVIG and aspirin. One group will also receive prednisolone, either as a liquid or tablet by mouth, or through a vein if needed, for two to three weeks. If your child still has a fever or swelling after starting treatment, doctors will give them extra medication regardless of their group.

Most children stay in hospital for the first 5 to 7 days of treatment, which is normal for Kawasaki disease. After leaving the hospital, there will be just three follow-up visits over a 12-week period. During these visits, doctors will check your child's recovery using blood tests and painless heart ultrasound scans (echocardiograms) to see how the heart arteries are healing.

Potential risks and benefits

Taking part may not directly benefit your child, but if steroids are proven effective, children receiving them may have a lower risk of heart complications. The results will also help doctors provide better care for children with Kawasaki disease in the future. Prednisolone is widely used in children, but it can cause temporary side effects such as mood changes, an increased appetite, tummy upset, or slightly raised blood pressure. Joining is completely voluntary, and you can withdraw your child from the study at any point without it affecting their normal NHS care.

Locations (56)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Great Ormond Street Hospital For Children NHS Foundation Trust
City only
London, England
Guy's and St Thomas' NHS Foundation Trust
Unverified
London NO COUNTRY SPECIFIED, assuming England, England
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
City only
Newcastle-upon-Tyne, England
Belfast Health & Social Care Trust
City only
Belfast, Northern Ireland
NHS Greater Glasgow and Clyde
City only
Glasgow, Scotland
University Hospital Southampton NHS Foundation Trust
City only
Southampton, England
St George's University Hospitals NHS Foundation Trust
Unverified
London, England
Imperial College Healthcare NHS Trust
Unverified
London, England
Barts Health NHS Trust
Unverified
London, England
Whittington Health NHS Trust
Unverified
London, England
University College London Hospitals NHS Foundation Trust
Unverified
London, England
Sheffield Children's NHS Foundation Trust
Unverified
Sheffield, England

Common questions

Will my child definitely get the standard treatment for Kawasaki disease?

Yes. Every child in the trial receives the full, recommended standard treatment (IVIG and aspirin). No child is denied standard care.

What is an echocardiogram?

An echocardiogram is a heart ultrasound. It uses sound waves to create live pictures of your child's heart and blood vessels. It is completely painless and safe.

How is it decided which group my child goes into?

A computer programme assigns your child to a group at random, like flipping a coin. Neither you nor the doctor can choose the group, ensuring the study results are fair and reliable.

What happens if my child does not get better quickly?

Doctors will closely monitor your child's fever and blood tests. If the swelling does not settle within a few days, your child will receive extra treatments immediately, whichever group they are in.

Can we change our minds after joining?

Yes. You can withdraw your child from the trial at any time. Your decision will not change the quality or type of care your child receives from their medical team.

How to find out more

Molly Pursell

mrcctu.kdcaap@ucl.ac.uk +44 (0)20 7670 4930 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.