RecruitingOBSERVATIONAL

KIDSHEART AND BRAIN : Early EEG Surgery Congenital Heart Disease Predict Onset of Neurodevelopmental Disorders

This study, called KIDSHEART AND BRAIN, is investigating the link between early heart surgery in babies and their brain development. Many babies born with heart conditions now survive thanks to better surgery, but some may later face challenges like learning difficulties or attention problems. The researchers want to use special brain scans, called EEGs, during and after heart surgery to find early clues about which babies might be more at risk. The aim is to understand more about these conditions and help doctors give the best possible care and support to each child as they grow up.

At a glance

Status

Recruiting

Sponsor

University Hospital, Lille

Enrolment target

Start

10 Oct 2022

Estimated completion

13 Oct 2026

Neurodevelopmental Disorders Congenital Cardiomyopathy

What is this study about?

Heart conditions in babies are quite common, affecting about 1 in every 100 newborns. Thanks to amazing progress in heart surgery, more than 90% of these babies now grow up to be adults. While this is wonderful news, doctors and researchers are also looking at the long-term health of these individuals.

One area they are particularly interested in is brain development. Some children who have had heart surgery as babies may later experience what are called 'neurodevelopmental disorders'. This simply means they might have difficulties with things like learning, paying attention, or social interactions (sometimes called autism spectrum disorders). These challenges can affect their schooling, future jobs, and overall quality of life as they get older. Currently, about 30% to 60% of these young people might face such issues.

This KIDSHEART AND BRAIN study aims to find out if there are any early warning signs during heart surgery that could predict these later developmental challenges. By using a special brain test called an EEG (which is like listening to the brain's electrical activity), the researchers hope to spot any changes that could be linked to future problems. The goal is to understand how these conditions develop and, in the long run, to help doctors give children the right support and care tailored to their individual needs.

Key takeaways

Study looks at brain development in babies after heart surgery.
Uses existing brain scans (EEGs) during routine care.
Aims to understand challenges like learning or attention problems.
Could help doctors give better care to future babies.
No extra tests or visits for your child.

Who may be eligible?

This study is looking for very specific candidates: babies who are less than one year old and need heart surgery at the CHU of Lille hospital. The surgery must be for a heart condition that was present from birth.

Your baby would not be able to join the study if they don't need surgery before their first birthday, or if they have already had heart surgery in the past. Also, if parents do not agree for their child to take part, or if the child is not covered by social security, they would not be eligible. Finally, the study is only for babies having their operation at the CHU of Lille.

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 baby less than one year old?
Does your baby need heart surgery for a condition present since birth?
Will the surgery take place at CHU of Lille hospital?
Has your baby not had heart surgery before?

Answer every question to see your result.

What does participation involve?

The study does not involve any extra tests or visits for your child that aren't already part of their usual care for heart surgery. The researchers will simply use the information gathered from your child's standard medical care, including a special brain scan called an EEG, which is already planned for some babies having heart surgery. There are no new medications involved and no additional follow-up appointments solely for the study. The total duration of your child's participation would relate to the period around their heart surgery and possibly looking at their development over time, using existing medical records.

Potential risks and benefits

Taking part in this study may not directly benefit your child, as it primarily involves collecting information from their existing medical care to help future patients. However, the information gained could greatly improve our understanding of how heart surgery affects brain development, leading to better care for other children in the future. There are no additional risks to your child beyond those normally associated with their heart surgery and standard medical tests, as no new procedures are being introduced. You are free to withdraw your child from the study at any time without affecting their medical care.

Locations (1)

CHU de LILLE
Verified postcode
Lille, France· Recruiting

Common questions

What is an EEG?

An EEG (electroencephalogram) is a safe and painless test that measures the electrical activity in the brain. It's like listening to the brain's signals.

Will my baby have extra tests because of this study?

No, your baby will not have any extra tests. The study uses information and tests (like the EEG) that are already part of their standard heart surgery care.

What are 'neurodevelopmental disorders'?

These are conditions that affect how the brain develops, which can lead to difficulties with learning, attention, communication, or social skills.

How long does the study last for my child?

Your child's involvement in the study focuses on the period around their heart surgery, using existing medical information. There are no extra follow-up visits.

Can I change my mind about my child participating?

Yes, you can withdraw your child from the study at any time without giving a reason, and it will not affect their medical care.

How to find out more

Sylvie NGUYEN THE TICH, MD,PhD

sylvie.nguyenthetich@chu-lille.fr 0320445962 Official trial record

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