NCT05996211 The Swiss Neurodevelopmental Outcome Registry for Children With CHD
| NCT ID | NCT05996211 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Children's Hospital, Zurich |
| Condition | Neurodevelopmental Abnormality |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2019-01-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2019-01-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Introduction: Congenital heart disease (CHD) is the most frequent birth defect. As survival has significantly improved, attention has turned to neurodevelopmental outcomes of children undergoing heart surgery in early infancy. Since multiple risk factors contribute to neurodevelopmental alterations, a nationwide registry collecting data on medical characteristics, interventions, clinical course and neurodevelopment until school-age is needed to improve the quality of management, identify risk- and protective factors affecting neurodevelopment, and facilitate multicenter trials. Methods and analysis: The Swiss Outcome Registry for CHIldren with severe congenital heart Disease (ORCHID) is a nationwide, prospective, population-based patient registry developed (1) to collect baseline characteristics and clinical data of CHD patients operated with bypass-surgery or hybrid procedures in the first 6 weeks of life in Switzerland, (2) to monitor long-term neurodevelopment, and (3) to relate clinical characteristics and neurodevelopment to identify risk and protective factors in these children. This registry started data collection relating to pregnancy, birth, preoperative course, catheter-based and surgical treatment, postoperative course and reinterventions in 2019. The primary outcome includes standardised neurodevelopmental assessments at 9 to 12 months, 18 to 24 months and 5.5 to 6 years. Investigators expect to include 80 to 100 children per year. Correlation and regression analyses will be used to investigate risk- and protective factors influencing neurodevelopment. Ethics and dissemination of results: Swiss ORCHID received support by the Accentus Charitable Foundation, the Anna Mueller Grocholoski Foundation, the Swiss Society of Pediatric Cardiology, and the Corelina - Foundation and was approved by the cantonal ethics committees. Findings will be presented at national and international scientific meetings, and published in peer-reviewed journals. Results will also be shared with patient organizations, primary health care providers, and public health stakeholders to ensure a widespread dissemination of the results.
Eligibility 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.
Contact & Investigator
Walter Knirsch, MD
PRINCIPAL INVESTIGATOR
University Children's Hospital, Zurich
Frequently Asked Questions
Who can join the NCT05996211 clinical trial?
This trial is open to participants of all sexes, aged 1 Week or older, up to 6 Weeks, studying Neurodevelopmental Abnormality. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05996211 currently recruiting?
Yes, NCT05996211 is actively recruiting participants. Contact the research team at walter.knirsch@kispi.uzh.ch for enrollment information.
Where is the NCT05996211 trial being conducted?
This trial is being conducted at Bern, Switzerland, Lausanne, Switzerland, Zurich, Switzerland.
Who is sponsoring the NCT05996211 clinical trial?
NCT05996211 is sponsored by University Children's Hospital, Zurich. The principal investigator is Walter Knirsch, MD at University Children's Hospital, Zurich. The trial plans to enroll 1,000 participants.