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Impact of Thymectomy on Immunity in Infants After Cardiac Surgery

NCT07019857 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-04-16

No results posted yet for this study

Summary

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

  • Congenital Heart Defects
  • Thymectomy
  • Immunological Deficiency Syndrome

Interventions

DIAGNOSTIC_TEST

Blood sample collection at surgery time and 12 months later

each participant undergoes a blood test 1) at surgery time and 2) 12 months after surgery. These 5mL samples include: * Blood cell count * TREC dosage * Complete Lymphocytes immunophenotyping * Immunoglobulin dosage

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Alexis Chenouard, PH · Nantes University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-25
Primary Completion
2027-12-01
Completion
2027-12-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07019857 on ClinicalTrials.gov