Early EEG monitoring in children with congenital heart disease to predict neurodevelopmental disorders
Official title: Intérêt de l'électroencéphalogramme précoce en Chirurgie de Cardiopathie congénitale Pour prédire la Survenue de Troubles du neurodéveloppement
Run by University Hospital, Lille · NCT05658965 · Data updated 2026-11-12
This study is trying to see if early brain wave patterns in babies with heart problems can help predict future learning and development issues.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Day to 1 Year |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille, Hauts-de-France) |
| Status | Recruiting |
| Started | October 10, 2022 |
| Main results expected | October 13, 2026 |
| Study ends | October 13, 2026 |
| Registry record updated | April 24, 2026 |
| Trial ID | NCT05658965 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children under one year old who require cardiac surgery for congenital cardiopathy.
✕Probably not a fit
Patients who do not require surgery before one year old or have a history of cardiac surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on children under one year old who are undergoing cardiac surgery for congenital cardiopathy. It aims to identify early EEG markers that may predict the onset of neurodevelopmental disorders, such as intellectual deficiencies and autism spectrum disorders, which affect a significant percentage of these patients. By understanding the risk factors associated with surgery and the physiological mechanisms involved, the study seeks to improve follow-up care tailored to each child's specific needs. The findings could enhance the quality of life for these patients as they transition into adulthood.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and intervention strategies for children with congenital heart disease, potentially reducing the incidence of neurodevelopmental disorders.
How similar studies have gone: While there is ongoing research in related areas, this specific approach of using early EEG monitoring in this patient population is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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CHU de LILLE
Lille, Hauts-de-France, France Recruiting
Study contacts
- Study coordinator: Sylvie NGUYEN THE TICH, MD,PhD
- Email: sylvie.nguyenthetich@chu-lille.fr
- Phone: 0320445962
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.