Actively Recruiting
Impact of Thymectomy on Immune Response in Infants 12 Months After Cardiac Surgery: a Single-centre Prospective Study
Led by Nantes University Hospital · Updated on 2026-04-16
70
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the impact of thymus removal during heart surgery on immune system development in infants under 6 months old. Researchers aim to compare the effects of complete versus partial thymectomy on immune function, particularly T lymphocyte development, and how this influences infection risk after surgery. The study is prospective and interventional, conducted at a single center, and focuses on long-term immune outcomes following pediatric cardiac surgery. Infants undergoing cardiac surgery with cardiopulmonary bypass are divided into groups based on whether they receive complete thymectomy, partial thymectomy, or no thymus removal (control groups including cardiac surgery without thymectomy and non-cardiac surgery). Blood samples are collected twice: once during surgery and again 12 months later, to measure immune cell counts, antibody levels, and vaccine responses. Parents complete questionnaires on infections experienced by their child over the year following surgery. Participants are closely monitored through blood tests and infection tracking. At 12 months post-surgery, families return for a follow-up blood draw and review of infection data, followed by a consultation to discuss results and future care if needed. The study examines immune cell profiles, vaccine responses, and clinical infection outcomes to understand the long-term effects of thymectomy type on infant immunity and guide future surgical decisions.
CONDITIONS
Brief Title
Impact of Thymectomy on Immunity in Infants After Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged between 0 and 6 months
- Born at a gestational age greater than 37 weeks
- Scheduled for cardiac surgery with cardiopulmonary bypass at Nantes University Hospital
- Planned cardiopediatric follow-up at Nantes University Hospital
- Legal guardians have signed written consent for participation
- For control groups: children aged 0 to 6 months undergoing cardiac surgery without thymectomy or non-cardiac surgery with thymus preserved
- Control group surgeries include thoracotomy cardiac surgery or non-cardiac ENT or digestive surgery
- Planned follow-up at Nantes University Hospital for control groups
You will not qualify if you...
- Gestational age less than 37 weeks
- History of cardiac surgery with cardiopulmonary bypass
- Heart disease requiring additional surgery within 12 months after first surgery
- Previous partial or complete thymectomy
- Receiving long-term immunosuppressive treatment
- Post-operative follow-up planned outside Nantes University Hospital or planned relocation during follow-up
- Parental refusal to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Day of surgery
Participants undergo cardiac or non-cardiac surgery, including either complete or partial thymectomy or thymus preservation depending on surgical group assignment.
1 surgical visit (in-person)
Duration - 12 months
Participants have blood samples taken at surgery time and at 12 months postoperatively to assess immune function including T-cell and humoral responses.
2 blood draws (1 at surgery and 1 at 12 months post-surgery)
Duration - 12 months
Participants and their families complete an infection monitoring questionnaire over 12 months with a phone call at 6 months and follow-up visits at 12 months and 12.5 months to review results and plan further care if needed.
1 phone call at 6 months and 2 in-person visits at 12 months and 12.5 months
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
Research Team
A
Alexis Chenouard, PH
E
Evelyne Gauvard
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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