RecruitingNAINTERVENTIONAL

Impact of Thymectomy on Immunity in Infants After Cardiac Surgery

When babies need heart surgery, doctors sometimes remove a small gland called the thymus to get to the heart more easily. This gland is important for developing the immune system, which helps fight off sickness. This study at a hospital in France is looking into whether removing only part of the thymus, instead of all of it, could help babies keep a stronger immune system after their heart operation. They will compare babies who have all or part of their thymus removed, and some who don't have it removed at all. By checking blood samples and tracking infections for a year, they hope to find the best way to help babies stay healthy.

At a glance

Status

Recruiting

Phase

Sponsor

Nantes University Hospital

Enrolment target

Start

25 Jul 2025

Estimated completion

01 Dec 2027

Congenital Heart Defects Thymectomy Immunological Deficiency Syndrome

What is this study about?

When tiny babies need heart surgery, surgeons often have to remove a small gland called the thymus. This helps them see and work on the heart more easily. However, the thymus is very important, especially in the first few years of life, because it helps the body grow cells that fight infections. These cells are like tiny soldiers that protect us from germs and illnesses.

This study, called THYMIC, is trying to understand if removing all of the thymus might make it harder for babies to fight off infections later on, compared to removing only a part of it. The doctors want to see if leaving some of the thymus intact could help a baby's immune system stay stronger. They believe that if leaving part of the thymus is better for the baby's health, this could change how these surgeries are done in the future.

Researchers will carefully compare babies who have heart surgery and either all or part of their thymus removed, to a control group of babies who don't have their thymus removed during surgery. They will take a small blood sample during surgery and another one a year later to check the baby's immune system. Parents will also be asked to keep track of any infections their child gets during that first year. This will help the doctors see how well each group of babies can fight illnesses.

Key takeaways

This study explores how thymus removal during baby heart surgery affects their immune system.
It compares removing all vs. part of the thymus to see if it helps babies fight infections.
Your child's medical care and surgery won't change if they participate.
Involves two small blood tests and tracking infections for one year.
Results could help improve future heart surgery practices for babies.
Participation requires parental consent.

Who may be eligible?

This study is looking for babies between birth and six months old who were born full-term (not prematurely). They must be scheduled to have heart surgery at the Nantes University Hospital in France, or another type of surgery there for the control groups. It's important that your child will continue to have their follow-up care at the Nantes University Hospital so the study team can monitor them.

Babies would not be able to join the study if they were born prematurely (before 37 weeks), have already had heart surgery, or need more heart surgery within the next year. Also, babies who have already had their thymus removed or are taking medicines that suppress their immune system would not be able to participate. If your family plans to move away from Nantes University Hospital, your child also couldn't join.

Ultimately, your written permission as a parent or guardian is needed for your child to take part in this important research.

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 between birth and six months old?
Was your baby born full-term (after 37 weeks)?
Is your baby having heart surgery (or other surgery for controls) at Nantes University Hospital?
Will your child continue their follow-up care at Nantes University Hospital?
Has your child NOT had previous heart surgery or already had their thymus removed?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, their regular medical and surgical care will not change. The decision about whether to remove all or part of the thymus during heart surgery is made by the surgeon based on what's best for your child's specific situation. The study will involve two small blood tests for your child. The first blood sample will be taken during their surgery, and the second one will be taken about one year after the surgery during a routine follow-up visit. These blood samples will help researchers understand how your child's immune system is working.

During the year after surgery, you will also be asked to fill out a questionnaire. This questionnaire will help you keep a record of any infections your child might get during that time. The study will last for about one year after your child's surgery. Taking part will not change any of your child's regular hospital appointments.

Potential risks and benefits

There are no direct medical benefits for your child from taking part in this study, as it won't change their medical or surgical treatment. However, the information gathered could help improve care for many other babies needing similar heart surgeries in the future. The risks involved are minimal, mainly from the two small blood tests, which are done safely and follow all regulations. Parents have the full right to remove their child from the study at any time without it affecting their medical care.

Locations (2)

CHU de Nantes
Verified postcode
Nantes, France· Not yet recruiting
Chu de Nantes
Verified postcode
Nantes, France· Recruiting

Common questions

What is the thymus gland?

The thymus is a small gland behind your breastbone, important for developing a healthy immune system, especially in babies and young children.

Why is the thymus sometimes removed during heart surgery?

Surgeons sometimes remove the thymus to get better access to the heart, making the surgery easier and safer for the baby.

Will my child's surgery be different if they join the study?

No, joining the study will not change your child's heart surgery or their medical care at all. The surgeon will make decisions as usual.

What do the blood tests look for?

The blood tests check how well your child's immune system is working by looking at special cells that fight infections and how they respond to vaccines.

How long will my child be part of this study?

Your child will be part of the study for about one year after their surgery, with a second blood test and a questionnaire at the end of that year.

How to find out more

Alexis Chenouard, PH

alexis.chenouard@chu-nantes.fr 02 44 76 82 21 Official trial record

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