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

NCT04295239 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-07-29

No results posted yet for this study

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.

Conditions

  • Congenital Heart Disease in Children
  • Extracorporeal Circulation; Complications

Interventions

PROCEDURE

MRI

Pre and Post operative MRI

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-10
Primary Completion
2022-02-19
Completion
2022-02-19

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04295239 on ClinicalTrials.gov