ClinicalTrials.Veeva

Menu

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

U

University Hospital, Lille

Status

Enrolling

Conditions

Congenital Cardiomyopathy
Neurodevelopmental Disorders

Study type

Observational

Funder types

Other

Identifiers

NCT05658965
2022-A00335-38 (Other Identifier)
2021_0160

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

1 day to 1 year old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

Loading...

Central trial contact

Sylvie NGUYEN THE TICH, MD,PhD; Sylvie JORIOT, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems