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

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease in Children; Extracorporeal Circulation; Complications
• Intervention / Treatment: Procedure: MRI

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • CHU de Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRI; Pre-operative AND post-operative MRI	Procedure: MRI; Pre and Post operative MRI

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Actual): February 19, 2022
• Study Completion (Actual): February 19, 2022

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: RC19_0413

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No