KIDSHEART AND BRAIN : Early EEG Surgery Congenital Heart Disease Predict Onset of Neurodevelopmental Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-1
SponsorUniversity Hospital, Lille
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Child with no necessity of surgery before 1 year old.
Medical history of cardiac surgery.
Refusal of consent by the parents.
No social security.
Trial population
Children of less than 1 year suffering of congenital cardiopathy admitted for cardiac surgery on extracorporal circulation on the CHU of Lille.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Interest of pre and post surgery EEG on neurodevelopmental disorders
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.
Time frame
Age of patient : 24 MonthsSecondary outcomes
1
Association between orality disorders and neurodevelopmental disorders
Association between the presence of pre surgery and 1 year old orality disorder and occurence of neurodevelopmental disorders.
Time frame
Age of patient : 24 Months2
Interest of post surgery EEG neurodevelopmental disorders at 24 months old
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.
Time frame
Age of patient : 24 MonthsSponsors and contacts
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Source ClinicalTrials.gov