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/NCT06031831</url>
    </required_header>
    <id_info>
      <org_study_id>202205043RINB</org_study_id>
      <nct_id>NCT06031831</nct_id>
    </id_info>
    <brief_title>Analysis of Risk Factors and Prognosis of Pediatric Patients After Operations for Congenital Heart Disease</brief_title>
    <official_title>Analysis of Epidemiology, Risk Factors, and Prognosis of Pediatric Patients After Operations for Congenital Heart Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan University Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This hospital-based retrospective study reviewed patients who underwent surgery for CHD&#xD;
        between 2017 and 2020 and analyzed the clinical features and outcomes associated with airway&#xD;
        anomalies.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">May 15, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Actual">December 31, 2022</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>Other</time_perspective>
    </study_design_info>
    <target_duration>5 Years</target_duration>
    <primary_outcome>
      <measure>surgical mortality</measure>
      <time_frame>1 year</time_frame>
      <description>hospital expired after operation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>intermediate survival</measure>
      <time_frame>5 years</time_frame>
      <description>expired during follow-up</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>post-operative ICU stay</measure>
      <time_frame>1 year</time_frame>
      <description>The length of ICU stay after operation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>post-operative intubated days</measure>
      <time_frame>1 year</time_frame>
      <description>The length of intubated days after operation</description>
    </secondary_outcome>
    <enrollment type="Anticipated">999</enrollment>
    <condition>Congenital Heart Disease</condition>
    <condition>Pediatric</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>airway anomalies</intervention_name>
      <description>with or without airway anomalies</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All pediatric patients (age &lt;18 years) who underwent surgery for CHD at our hospital&#xD;
          between January 1, 2017, and December 31, 2020&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  all pediatric patients (age &lt;18 years) who underwent surgery for CHD at our hospital&#xD;
               between January 1, 2017, and December 31, 2020.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  with much missing clinical data&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>0 Days</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Jenghung Wu</name>
        <address>
          <city>Taipei City 100</city>
          <state>Taiwan R.</state>
          <zip>100229</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 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>Heart Diseases</mesh_term>
      <mesh_term>Heart Defects, Congenital</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06031831
  org study id: 202205043RINB
  nct id: NCT06031831
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This hospital-based retrospective study reviewed patients who underwent surgery for CHD
        between 2017 and 2020 and analyzed the clinical features and outcomes associated with airway
        anomalies.
  observational model: Cohort
  time perspective: Other
  measure: surgical mortality
  time frame: 1 year
  description: hospital expired after operation
  measure: intermediate survival
  time frame: 5 years
  description: expired during follow-up
  measure: post-operative ICU stay
  time frame: 1 year
  description: The length of ICU stay after operation
  measure: post-operative intubated days
  time frame: 1 year
  description: The length of intubated days after operation
  intervention type: Other
  intervention name: airway anomalies
  description: with or without airway anomalies
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 0 Days
  maximum age: 18 Years
  healthy volunteers: No
  facility: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Heart Diseases
  mesh term: Heart Defects, Congenital
  sharing ipd: Undecided