Evaluating brain blood flow regulation in infants with congenital heart disease
The Impact of Perioperative Neurovascular Coupling on Outcome in Infants With Congenital Heart Disease.
Universitaire Ziekenhuizen KU Leuven · NCT06190210
This study looks at how blood flow to the brain works in infants with congenital heart disease to see if it affects their brain development and helps create better follow-up care for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | N/A to 6 Months |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven (other) |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06190210 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between cerebral autoregulation and neurovascular coupling in infants diagnosed with congenital heart disease (CHD). It aims to identify peri-operative physiological risk factors that may affect brain maturation and contribute to neurodevelopmental disorders. By utilizing electroencephalography (EEG) and near-infrared spectroscopy, the study seeks to develop a risk model and guidelines for standardized developmental follow-up in this vulnerable population. The research focuses on infants requiring surgical or percutaneous intervention within their first six months of life.
Who should consider this trial
Good fit: Ideal candidates for this study are infants with congenital heart disease who require a first surgical or percutaneous intervention within the first six months of life.
Not a fit: Patients who may not benefit from this study include those with syndromes or genetic conditions associated with neurological impairment or those requiring treatment after six months of life.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and intervention strategies for infants with congenital heart disease, potentially enhancing their neurodevelopmental outcomes.
How similar studies have performed: While the specific approach of this study may be novel, other studies have explored neurodevelopmental outcomes in infants with congenital heart disease, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * CHD warranting a first percutaneous or surgical intervention in the first 6 months, including but not limited to transposition of the great arteries (TGA), univentricular heart (UVH), Tetralogy of Fallot (TOF), coarctation of the aorta (CoA), total abnormal pulmonary venous drainage (TAPVU), Common arterial trunc (TA), large patent ductus arteriosus (PDA) or VSD and AVSD for which treatment is necessary within the first 6 months of life. * Treatment provided at the University Hospitals Leuven. Exclusion Criteria: * Syndromes or proven genetic conditions which are associated with neurological impairment * CHD warranting treatment after 6 months of life * Suspected or proven metabolic diseases * No parental/guardian consent
Where this trial is running
Leuven, Vlaams-Brabant
- UZ Leuven — Leuven, Vlaams-Brabant, Belgium (RECRUITING)
Study contacts
- Study coordinator: Liselotte Van Loo, MD
- Email: liselotte.vanloo@uzleuven.be
- Phone: +3216346057
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.
Conditions: Congenital Heart Disease, Neurodevelopmental Disorders, Electroencephalography, Near-Infrared Spectroscopy, Biomarkers, Congenital heart disease, Neurodevelopment, Neuromonitoring