The Swiss Neurodevelopmental Outcome Registry for Children With CHD

Congenital Heart Disease Clinical Trial

— SwissORCHID  

Official title:

The Swiss Neurodevelopmental Outcome Registry for Children With CHD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05996211
• Other study ID #: Knirsch 02
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2032

Study information

• Verified date: August 2023
• Source: University Children's Hospital, Zurich
• Contact: Walter Knirsch, MD
• Phone: +41 44 266 7111
• Email: walter.knirsch[@]kispi.uzh.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2032
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Week to 6 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Disease
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Intensive Care Neurological Disorder
• Nervous System Diseases
• Neurodevelopmental Abnormality

Locations

Country	Name	City	State
Switzerland	University of Bern	Bern
Switzerland	University of Lausanne	Lausanne
Switzerland	University Children's Hospital	Zurich

Sponsors (4)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich	University of Bern, University of Geneva, Switzerland, University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Natterer J, Schneider J, Sekarski N, Rathke V, Adams M, Latal B, Borradori-Tolsa BT, Bouhabib M, Fuhrer Kradolfer K, Glockler M, Hutter D, Kelly J, L'Ebraly C, Pfluger MR, Polito A, von Rhein M, Knirsch W. ORCHID (Outcome Registry for CHIldren with severe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bayley scales of infant and toddler development III at one year of age	Neurodevelopmental outcome measurement at one year of age (normal value 100, higher values mean better outcome)	One year of age
Primary	Bayley scales of infant and toddler development III at two years of age	Neurodevelopmental outcome measurement at two years of age (normal value 100, higher values mean better outcome)	Two years of age
Primary	Bayley scales of infant and toddler development III at five years of age	Neurodevelopmental outcome measurement at five years of age (normal value 100, higher values mean better outcome)	Five years of age

External Links

•   Publication of Swiss ORCHID