Actively Recruiting

Phase Not Applicable
Age: 0 - 6Months
All Genders
NCT07019857

Impact of Thymectomy on Immunity in Infants After Cardiac Surgery

Led by Nantes University Hospital · Updated on 2026-04-16

70

Participants Needed

2

Research Sites

122 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Heart surgery in infants typically involves complete removal of the thymus gland to improve access to the heart. However, the thymus plays a key role in developing the immune system in early childhood, especially in the production and maturation of T lymphocytes, which help the body defend itself against infections. The THYMIC study tests the hypothesis that partial removal of the thymus (partial thymectomy) during heart surgery may better preserve the child's immune function compared to total removal (complete thymectomy). The goal is to determine whether this conservative surgical approach could reduce the risk of immune system impairment and infections in the months following surgery. This is a prospective, interventional, single-center study conducted at CHU de Nantes, involving 3 groups of infants: * One group undergoing heart surgery with complete thymectomy; * One group undergoing heart surgery with partial thymectomy; * One control group undergoing heart or non-heart surgery without thymus removal. All infants enrolled will have two blood tests: one taken during their surgery and one taken one year later. These blood tests will quantify immune cells (T, B, NK cells), levels of antibodies, and vaccine responses. Parents will also be asked to fill out a questionnaire to record any infections their child experiences during the year after surgery. By comparing the immune responses and infection rates among the groups, the researchers hope to better understand the long-term effects of thymectomy in infants. The results could support future recommendations to preserve part of the thymus when possible during heart surgery. Participation in the study does not change the medical or surgical care of the child. The decision to perform a partial or complete thymectomy is made by the surgeon based on the child's anatomy. The additional blood samples are small in volume and follow current safety regulations.

CONDITIONS

Official Title

Impact of Thymectomy on Immunity in Infants After Cardiac Surgery

Who Can Participate

Age: 0 - 6Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged between 0 and 6 months
  • Born at a gestational age greater than 37 weeks
  • Indicated for cardiac surgery under cardiopulmonary bypass at Nantes University Hospital
  • Cardiopediatric follow-up planned at Nantes University Hospital
  • Written consent signed by legal guardians to participate in the study
  • For control group A: children aged 0 to 6 months, born after 37 weeks, indicated for thoracotomy cardiac surgery at Nantes University Hospital, with planned cardiopediatric follow-up and signed consent
  • For control group B: children aged 0 to 6 months, born after 37 weeks, indicated for non-cardiac surgery such as ENT or visceral surgery at Nantes University Hospital, with planned surgical follow-up and signed consent
Not Eligible

You will not qualify if you...

  • Gestational age less than 37 weeks
  • History of cardiac surgery under cardiopulmonary bypass
  • Heart disease requiring further surgery within 12 months of the first surgery
  • History of partial or complete thymectomy
  • Receiving long-term immunosuppressive treatment
  • Postoperative follow-up planned outside Nantes University Hospital or planned change of residence during follow-up
  • Parental refusal to participate

AI-Screening

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Trial Site Locations

Total: 2 locations

1

CHU de Nantes

Nantes, France, 44093

Not Yet Recruiting

2

Chu de Nantes

Nantes, France, 44093

Actively Recruiting

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Research Team

A

Alexis Chenouard, PH

CONTACT

E

Evelyne Gauvard

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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