Clinical trial NCT05658965: KIDSHEART AND BRAIN : Early EEG Surgery Congenital Heart Disease Predict Onset of Neurodevelopmental Disorders
Official title: Intérêt de l'électroencéphalogramme précoce en Chirurgie de Cardiopathie congénitale Pour prédire la Survenue de Troubles du neurodéveloppement
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurodevelopmental Disorders
Congenital Cardiomyopathy
Keywords: EEG
Neurodevelopmental Disorders
Congenital Cardiomyopathy
Orality Disorders
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children of less than 1 year suffering of congenital cardiopathy admitted for cardiac surgery on extracorporal circulation on the CHU of 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Interest of pre and post surgery EEG on neurodevelopmental disorders
timeFrame: Age of patient : 24 Months
Secondary outcomes:
measure: Association between orality disorders and neurodevelopmental disorders
timeFrame: Age of patient : 24 Months
measure: Interest of post surgery EEG neurodevelopmental disorders at 24 months old
timeFrame: Age of patient : 24 Months
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU de LILLE
state: Hauts De France
Study officials:
affiliation: CHU de Lille
name: Flavien GAUTRON, CRA
role: STUDY_CHAIR
affiliation: CHU de Lille
name: Gaëlle GUYOT, CRA
role: STUDY_CHAIR
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