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SwissORCHID: The Swiss Neurodevelopmental Outcome Registry for Children With CHD

Sponsor
University Children's Hospital, Zurich (Other)
Overall Status
Recruiting
CT.gov ID
NCT05996211
Collaborator
University of Lausanne Hospitals (Other), University of Geneva, Switzerland (Other), University of Bern (Other)
1,000
Enrollment
3
Locations
168
Anticipated Duration (Months)
333.3
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Swiss Neurodevelopmental Outcome Registry for Children With CHD
    Actual Study Start Date :
    Jan 1, 2019
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Dec 31, 2032

    Outcome Measures

    Primary Outcome Measures

    1. Bayley scales of infant and toddler development III at one year of age [One year of age]

      Neurodevelopmental outcome measurement at one year of age (normal value 100, higher values mean better outcome)

    2. Bayley scales of infant and toddler development III at two years of age [Two years of age]

      Neurodevelopmental outcome measurement at two years of age (normal value 100, higher values mean better outcome)

    3. Bayley scales of infant and toddler development III at five years of age [Five years of age]

      Neurodevelopmental outcome measurement at five years of age (normal value 100, higher values mean better outcome)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Week to 6 Weeks
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Bern Bern Switzerland
    2 University of Lausanne Lausanne Switzerland
    3 University Children's Hospital Zurich Switzerland 8032

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Walter Knirsch, MD, University Children's Hospital, Zurich

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    University Children's Hospital, Zurich
    ClinicalTrials.gov Identifier:
    NCT05996211
    Other Study ID Numbers:
    • Knirsch 02
    First Posted:
    Aug 18, 2023
    Last Update Posted:
    Aug 18, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Nervous System Diseases
    Heart Diseases
    Heart Defects, Congenital

    Study Results

    No Results Posted as of Aug 18, 2023