KIDSHEART AND BRAIN : Early EEG Surgery Congenital Heart Disease Predict Onset of Neurodevelopmental Disorders
NCT ID: NCT05658965
Last Updated: 2022-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2022-10-10
2025-10-10
Brief Summary
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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
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Child with congenital cardiopathy with necessity to be operated before 1 year old.
Exclusion Criteria
* Medical history of cardiac surgery.
* Refusal of consent by the parents.
* No social security.
* Child not operated on the CHU of LILLE.
1 Day
1 Year
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Flavien GAUTRON, CRA
Role: STUDY_CHAIR
CHU de Lille
Gaëlle GUYOT, CRA
Role: STUDY_CHAIR
CHU de Lille
Locations
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CHU de LILLE
Lille, Hauts-de-France, France
Countries
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Central Contacts
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Facility Contacts
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Sylvie NGUYEN THE TICH, MD, PhD
Role: primary
Sylvie JORIOT, MD
Role: backup
References
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Other Identifiers
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2022-A00335-38
Identifier Type: OTHER
Identifier Source: secondary_id
2021_0160
Identifier Type: -
Identifier Source: org_study_id