xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05996211</url>
    </required_header>
    <id_info>
      <org_study_id>Knirsch 02</org_study_id>
      <nct_id>NCT05996211</nct_id>
    </id_info>
    <brief_title>The Swiss Neurodevelopmental Outcome Registry for Children With CHD</brief_title>
    <acronym>SwissORCHID</acronym>
    <official_title>The Swiss Neurodevelopmental Outcome Registry for Children With CHD</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Children's Hospital, Zurich</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Lausanne Hospitals</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Geneva, Switzerland</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Bern</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Children's Hospital, Zurich</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Introduction: Congenital heart disease (CHD) is the most frequent birth defect. As survival&#xD;
        has significantly improved, attention has turned to neurodevelopmental outcomes of children&#xD;
        undergoing heart surgery in early infancy. Since multiple risk factors contribute to&#xD;
        neurodevelopmental alterations, a nationwide registry collecting data on medical&#xD;
        characteristics, interventions, clinical course and neurodevelopment until school-age is&#xD;
        needed to improve the quality of management, identify risk- and protective factors affecting&#xD;
        neurodevelopment, and facilitate multicenter trials.&#xD;
  &#xD;
        Methods and analysis: The Swiss Outcome Registry for CHIldren with severe congenital heart&#xD;
        Disease (ORCHID) is a nationwide, prospective, population-based patient registry developed&#xD;
        (1) to collect baseline characteristics and clinical data of CHD patients operated with&#xD;
        bypass-surgery or hybrid procedures in the first 6 weeks of life in Switzerland, (2) to&#xD;
        monitor long-term neurodevelopment, and (3) to relate clinical characteristics and&#xD;
        neurodevelopment to identify risk and protective factors in these children. This registry&#xD;
        started data collection relating to pregnancy, birth, preoperative course, catheter-based and&#xD;
        surgical treatment, postoperative course and reinterventions in 2019. The primary outcome&#xD;
        includes standardised neurodevelopmental assessments at 9 to 12 months, 18 to 24 months and&#xD;
        5.5 to 6 years. Investigators expect to include 80 to 100 children per year. Correlation and&#xD;
        regression analyses will be used to investigate risk- and protective factors influencing&#xD;
        neurodevelopment.&#xD;
  &#xD;
        Ethics and dissemination of results: Swiss ORCHID received support by the Accentus Charitable&#xD;
        Foundation, the Anna Mueller Grocholoski Foundation, the Swiss Society of Pediatric&#xD;
        Cardiology, and the Corelina - Foundation and was approved by the cantonal ethics committees.&#xD;
        Findings will be presented at national and international scientific meetings, and published&#xD;
        in peer-reviewed journals. Results will also be shared with patient organizations, primary&#xD;
        health care providers, and public health stakeholders to ensure a widespread dissemination of&#xD;
        the results.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2019</start_date>
    <completion_date type="Anticipated">December 31, 2032</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>10 Years</target_duration>
    <primary_outcome>
      <measure>Bayley scales of infant and toddler development III at one year of age</measure>
      <time_frame>One year of age</time_frame>
      <description>Neurodevelopmental outcome measurement at one year of age (normal value 100, higher values mean better outcome)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Bayley scales of infant and toddler development III at two years of age</measure>
      <time_frame>Two years of age</time_frame>
      <description>Neurodevelopmental outcome measurement at two years of age (normal value 100, higher values mean better outcome)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Bayley scales of infant and toddler development III at five years of age</measure>
      <time_frame>Five years of age</time_frame>
      <description>Neurodevelopmental outcome measurement at five years of age (normal value 100, higher values mean better outcome)</description>
    </primary_outcome>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Neurodevelopmental Abnormality</condition>
    <condition>Congenital Heart Disease</condition>
    <condition>Cardiac Disease</condition>
    <condition>Intensive Care Neurological Disorder</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with severe CHD&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Neonates (including preterm born children) with severe CHD&#xD;
  &#xD;
            -  Requiring an invasive cardiac intervention (including heart-lung-machine) within the&#xD;
               first 6 weeks of life.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Neonates (including preterm born children) with simple CHD&#xD;
  &#xD;
            -  Requiring simple cardiac surgery or catheter intervention such as closure of patent&#xD;
               arterial duct or simple repair of aortic coarctation without heart-lung-machine and&#xD;
               low impact on neurodevelopmental outcome.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Week</minimum_age>
      <maximum_age>6 Weeks</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Walter Knirsch, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Children's Hospital, Zurich</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Walter Knirsch, MD</last_name>
      <phone>+41 44 266 7111</phone>
      <email>walter.knirsch@kispi.uzh.ch</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Bern</name>
        <address>
          <city>Bern</city>
          <country>Switzerland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Damian Hutter, MD</last_name>
        <email>damian.hutter@insel.ch</email>
      </contact>
      <contact_backup>
        <last_name>Walter H Knirsch, MD</last_name>
        <phone>+41442667617</phone>
        <email>walter.knirsch@kispi.uzh.ch</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>University of Lausanne</name>
        <address>
          <city>Lausanne</city>
          <country>Switzerland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nicole Sekarski, MD</last_name>
        <email>nicole.sekarski@chuv.ch</email>
      </contact>
      <contact_backup>
        <last_name>Walter Knirsch, MD</last_name>
        <email>walter.knirsch@kispi.uzh.ch</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>University Children's Hospital</name>
        <address>
          <city>Zurich</city>
          <zip>8032</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Walter H Knirsch, MD</last_name>
        <phone>+41442667617</phone>
        <email>walter.knirsch@kispi.uzh.ch</email>
      </contact>
      <contact_backup>
        <last_name>H</last_name>
      </contact_backup>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/?term=%22Swiss+medical+weekly%22%5BJournal%5D+AND+2022%2F9%2F2%5BDate+-+Publication%5D</url>
      <description>Publication of Swiss ORCHID</description>
    </link>
    <results_reference>
      <citation>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.</citation>
      <PMID>36074038</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Nervous System Diseases</mesh_term>
      <mesh_term>Heart Diseases</mesh_term>
      <mesh_term>Heart Defects, Congenital</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05996211
  org study id: Knirsch 02
  nct id: NCT05996211
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: Bayley scales of infant and toddler development III at one year of age
  time frame: One year of age
  description: Neurodevelopmental outcome measurement at one year of age (normal value 100, higher values mean better outcome)
  measure: Bayley scales of infant and toddler development III at two years of age
  time frame: Two years of age
  description: Neurodevelopmental outcome measurement at two years of age (normal value 100, higher values mean better outcome)
  measure: Bayley scales of infant and toddler development III at five years of age
  time frame: Five years of age
  description: Neurodevelopmental outcome measurement at five years of age (normal value 100, higher values mean better outcome)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Week
  maximum age: 6 Weeks
  healthy volunteers: No
  last name: Walter Knirsch, MD
  role: Principal Investigator
  affiliation: University Children's Hospital, Zurich
  last name: Walter Knirsch, MD
  phone: +41 44 266 7111
  email: walter.knirsch@kispi.uzh.ch
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Switzerland
  url: https://pubmed.ncbi.nlm.nih.gov/?term=%22Swiss+medical+weekly%22%5BJournal%5D+AND+2022%2F9%2F2%5BDate+-+Publication%5D
  description: Publication of Swiss ORCHID
  citation: 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
  responsible party type: Sponsor
  mesh term: Nervous System Diseases
  mesh term: Heart Diseases
  mesh term: Heart Defects, Congenital
  sharing ipd: No