Non-invasive Monitoring of Cerebral Self-regulation in Perioperative Neonatal Cardiac Surgery (NEMOCARD)
Primary Purpose
Congenital Heart Disease in Children, Extracorporeal Circulation; Complications
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional other trial for Congenital Heart Disease in Children
Eligibility Criteria
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
Sites / Locations
- Chu de Nantes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRI
Arm Description
Pre-operative AND post-operative MRI
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
describe predictive factors of postoperative encephalopathy
duration of extra-corporal circulation,
describe predictive factors of postoperative encephalopathy
duration of aortic clamp
describe predictive factors of postoperative encephalopathy
duration of selective cerebral perfusion,
describe predictive factors of postoperative encephalopathy
duration of hypothermia deepness
describe predictive factors of postoperative encephalopathy
duration of critical NIRS
describe predictive factors of postoperative encephalopathy
duration of critical median arterial pression (PAM)
Full Information
NCT ID
NCT04295239
First Posted
February 27, 2020
Last Updated
March 11, 2022
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04295239
Brief Title
Non-invasive Monitoring of Cerebral Self-regulation in Perioperative Neonatal Cardiac Surgery
Acronym
NEMOCARD
Official Title
Non-invasive Monitoring of Cerebral Self-regulation in Perioperative Neonatal Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
February 19, 2022 (Actual)
Study Completion Date
February 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease in Children, Extracorporeal Circulation; Complications
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Monocentric, prospective and pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI
Arm Type
Experimental
Arm Description
Pre-operative AND post-operative MRI
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Description
Pre and Post operative MRI
Primary Outcome Measure Information:
Title
determine the association between time spent outside individually determined cerebral self-regulatory limits and the development of brain lesions suggestive of low brain output.
Description
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.
Time Frame
6 weeks after cardiac surgery
Secondary Outcome Measure Information:
Title
describe association between time spent outside self-regulatory limits and the occurrence of postoperative encephalopathy defined by clinical and encephalographic criteria.
Description
duration of period outside cerebral self-regulatory limits, Standardized clinical examination according to Amiel Tison at hospital discharge.
Time Frame
6 weeks after cardiac surgery
Title
describe predictive factors of postoperative encephalopathy
Description
duration of extra-corporal circulation,
Time Frame
day 1 (cardiac surgery)
Title
describe predictive factors of postoperative encephalopathy
Description
duration of aortic clamp
Time Frame
day 1 (cardiac surgery)
Title
describe predictive factors of postoperative encephalopathy
Description
duration of selective cerebral perfusion,
Time Frame
day 1 (cardiac surgery)
Title
describe predictive factors of postoperative encephalopathy
Description
duration of hypothermia deepness
Time Frame
day 1 (cardiac surgery)
Title
describe predictive factors of postoperative encephalopathy
Description
duration of critical NIRS
Time Frame
day 1 (cardiac surgery)
Title
describe predictive factors of postoperative encephalopathy
Description
duration of critical median arterial pression (PAM)
Time Frame
day 1 (cardiac surgery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chu de Nantes
City
Nantes
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Non-invasive Monitoring of Cerebral Self-regulation in Perioperative Neonatal Cardiac Surgery
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