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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04295239
Other study ID # RC19_0413
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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