The Swiss Neurodevelopmental Outcome Registry for Children With CHD (SwissORCHID)

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease; Cardiac Disease; Neurodevelopmental Abnormality; Intensive Care Neurological Disorder

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Walter Knirsch, MD; Phone Number: +41 44 266 7111; Email: walter.knirsch@kispi.uzh.ch

Study Locations

• Switzerland
  • Bern, Switzerland
    • Recruiting
    • University of Bern
    • Contact: Walter H Knirsch, MD; Phone Number: +41442667617; Email: walter.knirsch@kispi.uzh.ch
    • Contact: Damian Hutter, MD; Email: damian.hutter@insel.ch
  • Lausanne, Switzerland
    • Recruiting
    • University of Lausanne
    • Contact: Nicole Sekarski, MD; Email: nicole.sekarski@chuv.ch
    • Contact: Walter Knirsch, MD; Email: walter.knirsch@kispi.uzh.ch
  • Zurich, Switzerland, 8032
    • Recruiting
    • University Children's Hospital
    • Contact: Walter H Knirsch, MD; Phone Number: +41442667617; Email: walter.knirsch@kispi.uzh.ch
    • Contact: H

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe CHD

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich
• Collaborators: University of Lausanne Hospitals; University of Bern; University of Geneva, Switzerland
• Investigators: Principal Investigator: Walter Knirsch, MD, University Children's hospital, Zürich

Publications and helpful links

General Publications

• 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 congenital heart Disease) a Swiss, nationwide, prospective, population-based, neurodevelopmental paediatric patient registry: framework, regulations and implementation. Swiss Med Wkly. 2022 Sep 2;152:w30217. doi: 10.4414/smw.2022.w30217. eCollection 2022 Aug 29.

Helpful Links

• Publication of Swiss ORCHID

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: August 8, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Nervous System Diseases; Heart Defects, Congenital
• Other Study ID Numbers: Knirsch 02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No