NCT05658965 KIDSHEART AND BRAIN : Early EEG Surgery Congenital Heart Disease Predict Onset of Neurodevelopmental Disorders
| NCT ID | NCT05658965 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Neurodevelopmental Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-10-10 |
| Primary Completion | 2026-10-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2022-10-10 with a primary completion date of 2026-10-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Flavien GAUTRON, CRA
STUDY CHAIR
CHU de Lille
Frequently Asked Questions
Who can join the NCT05658965 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 1 Year, studying Neurodevelopmental Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05658965 currently recruiting?
Yes, NCT05658965 is actively recruiting participants. Contact the research team at sylvie.nguyenthetich@chu-lille.fr for enrollment information.
Where is the NCT05658965 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT05658965 clinical trial?
NCT05658965 is sponsored by University Hospital, Lille. The principal investigator is Flavien GAUTRON, CRA at CHU de Lille. The trial plans to enroll 50 participants.