Examining brain growth in infants with congenital heart disease
Altered Cerebral Growth and Development in Infants With Congenital Heart Disease
This study looks at how brain growth and development in infants with complex congenital heart disease are affected from pregnancy through their first three years of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 0 Days to 6 Months |
| Sex | All |
| Sponsor | University Children's Hospital, Zurich Academic / other |
| Locations | 1 site (Zurich) |
| Trial ID | NCT04233775 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on infants diagnosed with complex congenital heart disease (CHD) and aims to assess their brain growth and development through serial MRI examinations. The study will track changes in cerebral development starting from the third trimester of pregnancy and continuing through key surgical interventions in the first three years of life. By analyzing the impact of various risk factors on neurodevelopmental outcomes, the research seeks to understand the long-term effects of CHD on cognitive abilities. The study will include fetuses and neonates undergoing open-heart surgery while excluding those with additional congenital malformations or infections.
Who should consider this trial
Good fit: Ideal candidates for this study are fetuses and neonates diagnosed with complex congenital heart disease who are scheduled for open-heart surgery.
Not a fit: Patients with additional congenital malformations, brain malformations, congenital infections, or those born preterm before 37 weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the neurodevelopmental challenges faced by infants with congenital heart disease, leading to improved care and interventions.
How similar studies have performed: While there is ongoing research in the area of congenital heart disease and neurodevelopment, this specific approach of using serial MRI examinations in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All fetuses and neonates with the diagnosis complex type of CHD undergoing open-heart surgery are prospectively enrolled Exclusion Criteria: a) Clinical evidence or suspicion of a congenital malformation or syndrome, b) brain malformation, c) congenital infection and d) preterms before 37 weeks. These criteria will exclude fetuses and newborns with other conditions that will impact neurodevelopmental outcome.
Where this trial is running
Zurich
- University Children's Hospital — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Walter H Knirsch, MD — University Children's Hospital, Pediatric Heart Center, Pediatric Cardiology
- Study coordinator: Walter H Knirsch, MD
- Email: walter.knirsch@kispi.uzh.ch
- Phone: +41442667617
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.