RecruitingOBSERVATIONAL

European Paediatric Non-Alcoholic Fatty Liver Disease Registry (EU-PNAFLD)

The EU-PNAFLD study is a big project in Europe collecting information about Non-Alcoholic Fatty Liver Disease (NAFLD) in children. This condition means there is too much fat in the liver, even if the child doesn't drink alcohol. Doctors and scientists who specialise in children's liver health and hormones are working together. They want to learn more about why NAFLD happens, how it affects children as they grow, and eventually find better ways to help them. By bringing together information from many hospitals, they hope to speed up research and develop new treatments for children with NAFLD.

At a glance

Status

Recruiting

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrolment target

2,000

Start

14 Nov 2017

Estimated completion

01 Nov 2047

Non-Alcoholic Fatty Liver Disease Non-alcoholic Fatty Liver Non-alcoholic Steatohepatitis

What is this study about?

This study, called the European Paediatric Non-Alcoholic Fatty Liver Disease Registry (EU-PNAFLD), is creating a network of hospitals and specialists across Europe. These experts, including liver doctors and hormone specialists, are all focused on understanding a liver condition in children called Non-Alcoholic Fatty Liver Disease (NAFLD). This condition means there's too much fat in a child's liver, which can sometimes lead to swelling and damage, even if they don't drink alcohol.

The main goal is to bring together information from real patients to build a large picture of NAFLD in children. They will use existing patient records and samples to learn more. This will help them understand how the disease develops over many years and what causes it. They are also linking up with a similar registry for adults with NAFLD, which will help them see how the condition might change from childhood into adulthood.

By gathering all this information, the researchers hope to achieve several important things. They want to make it easier to test new medicines or treatments in clinical trials. They also want to understand the exact ways NAFLD affects children's bodies and how it progresses over time. Ultimately, this will help doctors provide better care and potentially develop new strategies to help children with NAFLD in the future.

Key takeaways

This study collects information about a childhood liver condition called NAFLD.
It aims to better understand NAFLD in children across Europe.
Your child will not receive new treatments or have extra hospital visits for this study.
It uses existing medical records and test results.
Participation helps future research and care for children with NAFLD.
Your child's information is kept private, and you can withdraw at any time.

Who may be eligible?

Children who might be able to take part in this study are those who have been diagnosed with a type of Non-Alcoholic Fatty Liver Disease (NAFLD) before their 18th birthday. This means a doctor has found too much fat in their liver, which could range from just extra fat to swelling or scarring of the liver tissue.

The diagnosis must have been made using certain methods. This usually involves an ultrasound scan or other imaging tests showing fat in the liver. Doctors would also have ruled out other common reasons for liver problems, such as infections like hepatitis, certain genetic conditions, or very rarely, alcohol use.

Children definitely can't join if their fatty liver is caused by other specific medical conditions like certain genetic disorders, viral infections, or if they have had a liver transplant. Also, children who consume more than a small amount of alcohol each day would not be eligible.

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 my child under 18 years old?
Has a doctor told me my child has a type of Non-Alcoholic Fatty Liver Disease (NAFLD)?
Was this diagnosis made using tests like an ultrasound showing fat in the liver?
Have other causes for liver problems (like infections or certain genetic conditions) been ruled out for my child?
Does my child not have a history of regularly drinking alcohol?

Answer every question to see your result.

What does participation involve?

This study is a 'registry' study, which means it will mainly collect information from existing medical records and sometimes from samples already taken as part of your child's regular care. It's not a study where your child would be given a new drug or treatment to test. Your child won't need to visit the hospital more often than usual for this study. The information collected would be things like your child's diagnosis details, test results (like blood tests or scans), and how their condition has changed over time. There won't be any extra appointments, medications, or specific follow-up appointments solely for this study. The total duration of participation would match how long your child is followed up for their NAFLD care by their doctor.

Potential risks and benefits

The main benefit of taking part in this registry is helping doctors and scientists learn more about childhood NAFLD, which could lead to better understanding and treatment for children in the future. As this is an observational study using existing data, there are no direct medical risks or side effects for your child from participating. All information would be handled confidentially to protect your child's privacy. You have the right to withdraw your child's data from the registry at any time without affecting their medical care.

Locations (3)

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

Maastricht UMC
Verified postcode
Maastricht, Netherlands· Active not recruiting
Addenbrooke's Hospital
Verified postcode
Cambridge, United Kingdom· Recruiting
Birmingham Children's Hospital
Verified postcode
Birmingham, United Kingdom· Recruiting

Common questions

What is Non-Alcoholic Fatty Liver Disease (NAFLD)?

NAFLD means there's too much fat in the liver, even if the person doesn't drink alcohol. It can sometimes lead to liver damage over time.

Will my child receive new medicine in this study?

No, this is a 'registry' study, which means it collects information about NAFLD. Your child will not be given any new drugs or treatments as part of this study.

Will my child need extra hospital visits?

No, your child will not need any extra hospital visits or appointments specifically for this study. It uses information from their routine medical care.

Is my child's information kept private?

Yes, all personal and medical information collected for the study will be kept strictly confidential and anonymous to protect your child's privacy.

Can I change my mind about my child participating?

Yes, you can decide to withdraw your child's information from the study at any time without it affecting their medical care.

How to find out more

Jake P Mann, MRCPCH

jm2032@cam.ac.uk 0044124644 Official trial record

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