BridgeMD
New treatment option for Congenital Heart Defects
Official title Impact of Thymectomy on Immunity in Infants After Cardiac Surgery
ClinicalTrials.gov ID: NCT07019857
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 6
You may be able to join if
- \- 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:
You likely can't join if
- 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nantes, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 6 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nantes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.