An interventional study of MRI in Congenital Heart Disease in Children and Extracorporeal Circulation; Complications, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 0 Days to 28 Days. Per ClinicalTrials.gov, last updated 2024-07-29.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Other
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.
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This study's enrollment of 40 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
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Exclusion Criteria:
Pre-operative AND post-operative MRI
Procedure: MRI
Pre and Post operative MRI
determine the association between time spent outside individually determined cerebral autoregulation limits and the development of brain lesions suggestive of low brain output.
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.
Time frame: 6 weeks after cardiac surgery
describe association between time spent outside autoregulation limits and the occurrence of postoperative encephalopathy defined by clinical and encephalographic criteria.
duration of period outside cerebral autoregulation limits, Standardized clinical examination according to Amiel Tison at hospital discharge.
Time frame: 6 weeks after cardiac surgery
describe predictive factors of postoperative encephalopathy
duration of extra-corporal circulation,
Time frame: day 1 (cardiac surgery)
describe predictive factors of postoperative encephalopathy
duration of aortic clamp
Time frame: day 1 (cardiac surgery)
describe predictive factors of postoperative encephalopathy
duration of selective cerebral perfusion,
Time frame: day 1 (cardiac surgery)
describe predictive factors of postoperative encephalopathy
duration of hypothermia deepness
Time frame: day 1 (cardiac surgery)
describe predictive factors of postoperative encephalopathy
duration of critical NIRS
Time frame: day 1 (cardiac surgery)
describe predictive factors of postoperative encephalopathy
duration of critical median arterial pression (PAM)
Time frame: day 1 (cardiac surgery)
Plan to share: No
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Nantes University Hospital