Non-invasive Monitoring of Cerebral Self-regulation in Perioperative Neonatal Cardiac Surgery

Study Overview
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Brief Summary
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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 implicated in the appearance of these sequelae, and it is therefore essential to monitor brain function during ECC. The quality of cerebral oxygenation in the perioperative period is routinely monitored non-invasively by infra-red spectroscopy, which makes it possible to estimate cerebral tissue oximetry from a surface electrode (NIRS). The association between time spent outside the limits of cerebral self-regulation and the occurrence of perioperative encephalopathy is not known. The purpose of this study is to determine whether disturbances in brain self-regulation during the operative period are associated with the occurrence of postoperative encephalopathy in children operated on for congenital heart disease in the neonatal period. The main objective of the research is to determine the association between time spent outside individually determined cerebral self-regulation limits and the appearance of brain lesions suggestive of low brain output. Secondary objectives will investigate the association between time spent outside self-regulatory limits and the occurrence of postoperative encephalopathy defined by clinical and encephalographic criteria and will study factors predictive of the development of postoperative encephalopathy.

Official Title
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Non-invasive Monitoring of Cerebral Self-regulation in Perioperative Neonatal Cardiac Surgery

Conditions
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Congenital Heart Disease in Children, Extracorporeal Circulation; Complications

Intervention / Treatment
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* Procedure: MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Monocentric, prospective and pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI<br>Pre-operative AND post-operative MRI | Procedure: MRI<br>* Pre and Post operative MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine the association between time spent outside individually determined cerebral self-regulatory limits and the development of brain lesions suggestive of low brain output. | duration of period outside cerebral self-regulatory limits, Number, size and extent of new lesions on post-operative MRI. Patients will be classified into 2 categories according to whether or not there are new lesions on MRI. The lesions retained will be infarcts, white matter lesions and intraparenchymal hemorrhages, classified according to the Magnetic Resonance Imaging Abnormality Scoring System. | 6 weeks after cardiac surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| describe association between time spent outside self-regulatory limits and the occurrence of postoperative encephalopathy defined by clinical and encephalographic criteria. | duration of period outside cerebral self-regulatory limits, Standardized clinical examination according to Amiel Tison at hospital discharge. | 6 weeks after cardiac surgery | 
| describe predictive factors of postoperative encephalopathy | duration of extra-corporal circulation, | day 1 (cardiac surgery) | 
| describe predictive factors of postoperative encephalopathy | duration of aortic clamp | day 1 (cardiac surgery) | 
| describe predictive factors of postoperative encephalopathy | duration of selective cerebral perfusion, | day 1 (cardiac surgery) | 
| describe predictive factors of postoperative encephalopathy | duration of hypothermia deepness | day 1 (cardiac surgery) | 
| describe predictive factors of postoperative encephalopathy | duration of critical NIRS | day 1 (cardiac surgery) | 
| describe predictive factors of postoperative encephalopathy | duration of critical median arterial pression (PAM) | day 1 (cardiac surgery) |