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UnknownNCT05658965

KIDSHEART AND BRAIN : Early EEG Surgery Congenital Heart Disease Predict Onset of Neurodevelopmental Disorders

Intérêt de l'électroencéphalogramme précoce en Chirurgie de Cardiopathie congénitale Pour prédire la Survenue de Troubles du neurodéveloppement

Status
Unknown
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
University Hospital, Lille · Academic / Other
Sex
All
Age
1 Day – 1 Year
Healthy volunteers
Not accepted

Summary

Congenital cardiopathy are frequent malformations (1/100 birth). The progress of surgery permit a survival rate at the adult age of more than 90%. The long terms consequences must be taken in account and the nerodevelopmental disorders are in first place (intelectual deficiency, autism spectrum disorders, or attention disorders) and presents in 30 to 60% of the patients (Calmant, 2015). The impact can be important on the scolarity, the studies, the professional activity and finaly on the quality of life of the patients becomming adults. The identification of the risk factors on surgery period should permit to propose the most adapted follow-up to the specifics needs of each patients. On the scientific plans, the identification of early markers on brain dammage on EEG should permit to better apprehend the physiopathologic mecanisms involved.

Detailed description

Interest of early EEG on congenital cardiopathy surgery to predict the neurodevelopmental disorders occurence. Congenital cardiopathy are frequent malformations (1/100 birth). The progress of surgery permit a survival rate at the adult age of more than 90%. The long terms consequences must be taken in account and the nerodevelopmental disorders are in first place (intelectual deficiency, autism spectrum disorders, or attention disorders) and presents in 30 to 60% of the patients (Calmant, 2015). The impact can be important on the scolarity, the studies, the professional activity and finaly on the quality of life of the patients becomming adults. The identification of the risk factors on surgery period should permit to propose the most adapted follow-up to the specifics needs of each patients. On the scientific plans, the identification of early markers on brain dammage on EEG should permit to better apprehend the physiopathologic mecanisms involved.

Conditions

Timeline

Start date
2022-10-10
Primary completion
2025-10-10
Completion
2025-10-10
First posted
2022-12-21
Last updated
2022-12-21

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05658965. Inclusion in this directory is not an endorsement.