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Partial thymectomy may shield infant immunity after heart surgery

NCT ID NCT07019857

Knowledge-focused Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at infants having heart surgery, where the thymus gland is often fully removed to access the heart. The thymus helps build the immune system early in life. Researchers want to see if removing only part of the thymus keeps the immune system stronger and reduces infections. They will compare blood tests and infection records over one year in three groups: complete removal, partial removal, and no removal.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could guide surgeons to preserve part of the thymus during infant heart surgery, potentially reducing infection risks and improving immune health.
What could go wrong
This is a small, single-center observational study, not a treatment trial. It only measures immune markers and infection rates, so it cannot prove that partial thymectomy directly causes better outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 6 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * \- Children aged between 0 and 6 months; * Born at a gestational age \> 37 weeks' gestation; * With an indication for cardiac surgery under CEC at Nantes University Hospital; * Cardiopediatric follow-up planned at Nantes University Hospital; * Written agreement signed by legal guardians to participate in the study. For the control groups: * Control group A (cardiac surgery without thymectomy): * Children aged between 0 and 6 months of age; * Born at a gestational age \> 37 SA; * Indicated for thoracotomy cardiac surgery at Nantes University Hospital; * Cardiopediatric follow-up planned at Nantes University Hospital; * Written agreement signed by legal guardians to participate in the study. * Control group B (non-cardiac surgery) * Children aged between 0 and 6 months; * Born at a gestational age \> 37 SA; * Indicated for non-cardiac surgery (ENT or visceral surgery at Nantes University Hospital); * Planned follow-up surgery at Nantes University Hospital; * Written agreement signed by legal guardians to participate in the study. Exclusion Criteria : * Gestational age \< 37 SA; * With a history of cardiac surgery under ECG; * And/or with heart disease requiring further surgery within 12 months of the 1st surgery (e.g. pulmonary cerclage, systemic pulmonary anastomosis). * And/or a history of partial or complete thymectomy; * Receiving long-term immunosuppressive treatment; * Post-operative follow-up planned in a hospital other than Nantes University Hospital, or moving house planned during the follow-up period; * parental refusal. Exclusion Criteria: * \- Gestational age \< 37 SA; * With a history of cardiac surgery under ECG; * And/or with heart disease requiring further surgery within 12 months of the 1st surgery (e.g. pulmonary cerclage, systemic pulmonary anastomosis). * And/or a history of partial or complete thymectomy; * Receiving long-term immunosuppressive treatment; * Post-operative follow-up planned in a hospital other than Nantes University Hospital, or moving house planned during the follow-up period; * parental refusal.

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Conditions

The condition(s) this trial relates to.

congenital heart disease inborn error of immunity Infections

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital heart defects Immunological deficiency syndrome Thymectomy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU de Nantes

    NOT_YET_RECRUITING

    Nantes, 44093, France

  • Chu de Nantes

    RECRUITING

    Nantes, 44093, France

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