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

Recruiting

• Conditions: Congenital Cardiomyopathy; Neurodevelopmental Disorders

• Registration Number: NCT05658965
• Lead Sponsor: University Hospital, Lille

Brief 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.

Study Timeline

• Study Start: 2022-10-10
• Status Verified: 2022-11
• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2022-12-20
• Last Update Submitted: 2022-12-20
• Study First Posted: 2022-12-21
• Last Update Posted: 2022-12-21
• Primary Completion: 2025-10-10
• Study Completion: 2025-10-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Child of less than 1 year admitted for cardiac surgery on extracorporal circulation on the CHU of Lille during the study period.
• Child with congenital cardiopathy with necessity to be operated before 1 year old.

Exclusion Criteria

• Child with no necessity of surgery before 1 year old.
• Medical history of cardiac surgery.
• Refusal of consent by the parents.
• No social security.
• Child not operated on the CHU of LILLE.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Interest of pre and post surgery EEG on neurodevelopmental disorders	Age of patient : 24 Months	Evaluation of the interest of pre and post surgery EEG in the prediction of neurodevelopmental disorders on patients operated of congenital cardiopathy before the age of 1 year old.

Secondary Outcome Measures

Name	Time	Method
Association between orality disorders and neurodevelopmental disorders	Age of patient : 24 Months	Association between the presence of pre surgery and 1 year old orality disorder and occurence of neurodevelopmental disorders.
Interest of post surgery EEG neurodevelopmental disorders at 24 months old	Age of patient : 24 Months	Evaluation of the interest of 24 months old post surgery EEG in the prediction of neurodevelopmental disorders on patients operated of congenital cardiopathy before the age of 1 year old, having a normal pre surgery EEG.

Trial Locations

Locations (1)

CHU de LILLE; 🇫🇷 Lille, Hauts De France, France