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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
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05658965
Acronym
KHB
Enrollment
50
Registered
2022-12-21
Start date
2022-10-10
Completion date
2026-10-13
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Cardiomyopathy, Neurodevelopmental Disorders

Keywords

EEG, Neurodevelopmental Disorders, Congenital Cardiomyopathy, Orality Disorders

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.

Interventions

None listed

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 1 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Interest of pre and post surgery EEG on neurodevelopmental disordersAge of patient : 24 MonthsEvaluation 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

MeasureTime frameDescription
Association between orality disorders and neurodevelopmental disordersAge of patient : 24 MonthsAssociation 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 oldAge of patient : 24 MonthsEvaluation 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.

Countries

France

Contacts

CONTACTSylvie NGUYEN THE TICH, MD,PhD
sylvie.nguyenthetich@chu-lille.fr0320445962
CONTACTSylvie JORIOT, MD
sylvie.joriot@chu-lille.fr0320445962
STUDY_CHAIRFlavien GAUTRON, CRA

CHU de Lille

STUDY_CHAIRGaëlle GUYOT, CRA

CHU de Lille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026