Early EEG monitoring in children with congenital heart disease to predict neurodevelopmental disorders
Intérêt de l'électroencéphalogramme précoce en Chirurgie de Cardiopathie congénitale Pour prédire la Survenue de Troubles du neurodéveloppement
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 1 Day to 1 Year |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille, Hauts-de-France) |
| Trial ID | NCT05658965 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children under one year old who require cardiac surgery for congenital cardiopathy.
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.
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 performed: While there is ongoing research in related areas, this specific approach of using early EEG monitoring in this patient population is relatively novel.
Eligibility criteria
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 this trial is running
Lille, Hauts-de-France
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.