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

Congenital Heart Disease in Children Clinical Trial

— NEMOCARD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04295239
• Other study ID #: RC19_0413
• Status: Completed
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: February 19, 2022

Study information

• Verified date: March 2022
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 19, 2022
• Est. primary completion date: February 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease in Children
• Extracorporeal Circulation; Complications
• Heart Defects, Congenital
• Heart Diseases

Intervention

Procedure:
• MRI
Pre and Post operative MRI

Locations

Country	Name	City	State
France	Chu de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	describe predictive factors of postoperative encephalopathy	duration of extra-corporal circulation,	day 1 (cardiac surgery)
Secondary	describe predictive factors of postoperative encephalopathy	duration of aortic clamp	day 1 (cardiac surgery)
Secondary	describe predictive factors of postoperative encephalopathy	duration of selective cerebral perfusion,	day 1 (cardiac surgery)
Secondary	describe predictive factors of postoperative encephalopathy	duration of hypothermia deepness	day 1 (cardiac surgery)
Secondary	describe predictive factors of postoperative encephalopathy	duration of critical NIRS	day 1 (cardiac surgery)
Secondary	describe predictive factors of postoperative encephalopathy	duration of critical median arterial pression (PAM)	day 1 (cardiac surgery)