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NCT Number: NCT05658965

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

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.

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Key information

Age range

1 day–1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Interest of pre and post surgery EEG on neurodevelopmental disorders

    Time frame: 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 outcomes

  1. Association between orality disorders and neurodevelopmental disorders

    Time frame: Age of patient : 24 Months

    Association between the presence of pre surgery and 1 year old orality disorder and occurence of neurodevelopmental disorders.

  2. Interest of post surgery EEG neurodevelopmental disorders at 24 months old

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sylvie JORIOT, MD

CONTACT

[email protected]

0320445962 ext. +33

Sylvie NGUYEN THE TICH, MD,PhD

CONTACT

[email protected]

0320445962 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Intérêt de l'électroencéphalogramme précoce en Chirurgie de Cardiopathie congénitale Pour prédire la Survenue de Troubles du neurodéveloppement

Acronym: KHB

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 21, 2022
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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