Status:
COMPLETED
Non-invasive Monitoring of Cerebral Autoregulation in Perioperative Neonatal Cardiac Surgery
Lead Sponsor:
Nantes University Hospital
Conditions:
Congenital Heart Disease in Children
Extracorporeal Circulation; Complications
Eligibility:
All Genders
Up to 28 years
Phase:
NA
Brief Summary
Cardiac surgery under extracorporeal circulation (ECC) in newborns with congenital heart disease causes significant morbidity and mortality. The perioperative period is a period of major vulnerability...
Eligibility Criteria
Inclusion
- Any newborn (0-28 days) with congenital heart disease, hospitalized in the preoperative period at the Nantes University Hospital, for whom a decision is made to perform an operation under extracorporeal circulation, suitable to be transported for an MRI without risk, advice taken from the treating team.
Exclusion
- emergency cardiac surgery
- Preoperative extracorporeal assistance
- Preoperative intubation
- Preoperative administration of inotropes
- Pre-operative instability contra-indicating pre-operative MRI
- Dependence on a pace maker contra-indicating MRI Imaging.
- Parental consent refusal
- Non-affiliation to a health security insurance
Key Trial Info
Start Date :
March 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04295239
Start Date
March 10 2020
End Date
February 19 2022
Last Update
July 29 2024
Active Locations (1)
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1
Chu de Nantes
Nantes, France