The Swiss Neurodevelopmental Outcome Registry for Children With CHD

NCT ID: NCT05996211

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2032-12-31

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.

Conditions

Neurodevelopmental Abnormality; Congenital Heart Disease; Cardiac Disease; Intensive Care Neurological Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 1 Week
• Maximum Eligible Age: 6 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: collaborator

University of Geneva, Switzerland

OTHER

Sponsor Role: collaborator

University of Bern

OTHER

Sponsor Role: collaborator

University Children's Hospital, Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walter Knirsch, MD

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital, Zurich

Locations

University of Bern

Bern, , Switzerland

Site Status: RECRUITING

University of Lausanne

Lausanne, , Switzerland

Site Status: RECRUITING

University Children's Hospital

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Walter Knirsch, MD

Role: CONTACT

walter.knirsch@kispi.uzh.ch

+41 44 266 7111

Facility Contacts

Damian Hutter, MD

Role: primary

damian.hutter@insel.ch

Walter H Knirsch, MD

Role: backup

walter.knirsch@kispi.uzh.ch

+41442667617

Nicole Sekarski, MD

Role: primary

nicole.sekarski@chuv.ch

Walter Knirsch, MD

Role: backup

walter.knirsch@kispi.uzh.ch

Walter H Knirsch, MD

Role: primary

walter.knirsch@kispi.uzh.ch

+41442667617

H

Role: backup

References

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.

Reference Type: RESULT

PMID: 36074038 (View on PubMed)

Knirsch W, De Silvestro A, Rathke V, L'Ebraly C, Natterer JC, Schneider J, Sekarski N, Latal B, Borradori-Tolsa C, Bouhabib MS, Fuhrer Kradolfer K, Glockler M, Hutter D, Pfluger MR, Kaiser L, Polito A, Kelly-Geyer JF, von Rhein M; Swiss ORCHID group. Impact of postoperative necrotizing enterocolitis after neonatal cardiac surgery on neurodevelopmental outcome at 1 year of age. Front Pediatr. 2024 Aug 6;12:1380582. doi: 10.3389/fped.2024.1380582. eCollection 2024.

Reference Type: DERIVED

PMID: 39165487 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/?term=%22Swiss+medical+weekly%22%5BJournal%5D+AND+2022%2F9%2F2%5BDate+-+Publication%5D

Publication of Swiss ORCHID

Other Identifiers

Knirsch 02

Identifier Type: -

Identifier Source: org_study_id