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Clinical Trials/NCT04295239
NCT04295239
Completed
Not Applicable

Non-invasive Monitoring of Cerebral Autoregulation in Perioperative Neonatal Cardiac Surgery

Nantes University Hospital1 site in 1 country40 target enrollmentMarch 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease in Children
Sponsor
Nantes University Hospital
Enrollment
40
Locations
1
Primary Endpoint
determine the association between time spent outside individually determined cerebral autoregulation limits and the development of brain lesions suggestive of low brain output.
Status
Completed
Last Updated
last year

Overview

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 autoregulation and the occurrence of perioperative encephalopathy is not known. The purpose of this study is to determine whether disturbances in brain autoregulation 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 autoregulation limits and the appearance of brain lesions suggestive of low brain output. Secondary objectives will investigate the association between time spent outside autoregulatory limits and the occurrence of postoperative encephalopathy defined by clinical and encephalographic criteria and will study factors predictive of the development of postoperative encephalopathy.

Registry
clinicaltrials.gov
Start Date
March 10, 2020
End Date
February 19, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

determine the association between time spent outside individually determined cerebral autoregulation limits and the development of brain lesions suggestive of low brain output.

Time Frame: 6 weeks after cardiac surgery

duration of period outside cerebral autoregulation 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 Outcomes

  • describe predictive factors of postoperative encephalopathy(day 1 (cardiac surgery))
  • describe association between time spent outside autoregulation limits and the occurrence of postoperative encephalopathy defined by clinical and encephalographic criteria.(6 weeks after cardiac surgery)

Study Sites (1)

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