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

NCT05658965 | Recruiting DMC

• 2 other identifiers: 2021_01602022-A00335-38
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodevelopmental Disorders; Congenital Cardiomyopathy

Keywords

EEG; Neurodevelopmental Disorders; Congenital Cardiomyopathy; Orality Disorders

Outcome Measures

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.

  Age of patient : 24 Months

Secondary Outcomes (2)

• Association between orality disorders and neurodevelopmental disorders

  Age of patient : 24 Months

• Interest of post surgery EEG neurodevelopmental disorders at 24 months old

  Age of patient : 24 Months

Eligibility Criteria

• Age: 1 Day - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

CHU de LILLE

Lille, Hauts-de-France, 59037, France

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Neurodevelopmental Disorders; Cardiomyopathy, infantile histiocytoid

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Flavien GAUTRON, CRA

  CHU de Lille

  STUDY CHAIR

• Gaëlle GUYOT, CRA

  CHU de Lille

  STUDY CHAIR

Central Study Contacts

Sylvie NGUYEN THE TICH, MD,PhD

CONTACT

0320445962; sylvie.nguyenthetich@chu-lille.fr

Sylvie JORIOT, MD

CONTACT

0320445962; sylvie.joriot@chu-lille.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 21, 2022
• Study Start: October 10, 2022
• Primary Completion (Estimated): October 13, 2026
• Study Completion (Estimated): October 13, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)