Registry for tracking neurodevelopment in children with congenital heart disease
Official title: The Swiss Neurodevelopmental Outcome Registry for Children With CHD
Run by University Children's Hospital, Zurich · NCT05996211 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 1 Week to 6 Weeks |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | University Children's Hospital, Zurich Academic / other |
| Locations | 3 sites (Bern and 2 other locations) |
| Status | Recruiting |
| Started | January 1, 2019 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2032 |
| Registry record updated | August 18, 2023 |
| Trial ID | NCT05996211 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are neonates, including preterm infants, diagnosed with severe congenital heart disease requiring invasive cardiac interventions.
✕Probably not a fit
Patients with simple congenital heart disease or those undergoing low-impact cardiac procedures are unlikely to benefit from this study.
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 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.
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 gone: Other studies have shown success in tracking neurodevelopmental outcomes in similar populations, indicating that this approach is promising.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.