The Swiss Neurodevelopmental Outcome Registry for Children With CHD

NCT05996211 | Recruiting DMC

• 1 other identifier: Knirsch 02
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

• Age: 1 Week - 6 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe CHD

You may qualify if:

• Neonates (including preterm born children) with severe CHD
• Requiring an invasive cardiac intervention (including heart-lung-machine) within the first 6 weeks of life.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead
• University of Lausanne Hospitals: collaborator
• University of Geneva, Switzerland: collaborator
• University of Bern: collaborator

Study Sites (3)

University of Bern

Bern, Switzerland

RECRUITING

University of Lausanne

Lausanne, Switzerland

RECRUITING

University Children's Hospital

Zurich, 8032, Switzerland

RECRUITING

Related Publications (2)

• 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.

  PMID: 36074038 RESULT

• 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.

  PMID: 39165487 DERIVED

Related Links

• Publication of Swiss ORCHID

MeSH Terms

Conditions

Heart Defects, Congenital; Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Walter Knirsch, MD

  University Children's Hospital, Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Walter Knirsch, MD

CONTACT

+41 44 266 7111; walter.knirsch@kispi.uzh.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 18, 2023
• Study Start: January 1, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2032
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3)