Registry for tracking neurodevelopment in children with congenital heart disease
The Swiss Neurodevelopmental Outcome Registry for Children With CHD
This study is creating a national registry to track the development of young children with serious heart defects who have heart surgery early in life, to see how their health and treatments affect their growth and learning as they get older.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 1 Week to 6 Weeks |
| Sex | All |
| Sponsor | University Children's Hospital, Zurich Academic / other |
| Locations | 3 sites (Bern and 2 other locations) |
| Trial ID | NCT05996211 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a nationwide registry in Switzerland to collect data on children with severe congenital heart disease (CHD) who undergo invasive cardiac interventions within the first six weeks of life. The registry will gather information on medical characteristics, clinical interventions, and long-term neurodevelopmental outcomes until school age. By identifying risk and protective factors affecting neurodevelopment, the study seeks to improve management strategies and facilitate future multicenter trials.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates, including preterm infants, diagnosed with severe congenital heart disease requiring invasive cardiac interventions.
Not a fit: Patients with simple congenital heart disease or those undergoing low-impact cardiac procedures are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this registry could enhance the understanding of neurodevelopmental outcomes in children with CHD, leading to improved care and interventions.
How similar studies have performed: Other studies have shown success in tracking neurodevelopmental outcomes in similar populations, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Neonates (including preterm born children) with severe CHD * Requiring an invasive cardiac intervention (including heart-lung-machine) within the first 6 weeks of life. Exclusion Criteria: * Neonates (including preterm born children) with simple CHD * Requiring simple cardiac surgery or catheter intervention such as closure of patent arterial duct or simple repair of aortic coarctation without heart-lung-machine and low impact on neurodevelopmental outcome.
Where this trial is running
Bern and 2 other locations
- University of Bern — Bern, Switzerland (Recruiting)
- University of Lausanne — Lausanne, Switzerland (Recruiting)
- University Children's Hospital — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Walter Knirsch, MD — University Children's Hospital, Zurich
- Study coordinator: Walter Knirsch, MD
- Email: walter.knirsch@kispi.uzh.ch
- Phone: +41 44 266 7111
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.