Evaluating brain blood flow regulation in infants with congenital heart disease

Is this trial a fit for you?

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 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.

Why it matters

Who can join: the full rules

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 it's running

• UZ Leuven
  Leuven, Vlaams-Brabant, Belgium Recruiting

Study contacts

• Study coordinator: Liselotte Van Loo, MD
• Email: liselotte.vanloo@uzleuven.be
• Phone: +3216346057

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.