<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/NCT01679275</url>
  </required_header>
  <id_info>
    <org_study_id>S54683</org_study_id>
    <nct_id>NCT01679275</nct_id>
  </id_info>
  <brief_title>Pre-operative Cerebral Oxygenation in Neonates With Congenital Heart Disease</brief_title>
  <acronym>CHD-NIRS</acronym>
  <official_title>Longitudinal Pre-operative Measurements of Cerebral Oxygenation Using Near Infrared Spectroscopy in Neonates With Congenital Heart Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Congenital heart disease with need for early surgery in newborns is associated with an&#xD;
      increased incidence in global impairment in development. The causes of these late adverse&#xD;
      neurologic outcomes are multifactoral and include both fixed (or patient-specific factors)&#xD;
      and modifiable factors. They relate to both the mechanism of central nervous system injury&#xD;
      associated with congenital heart disease and its treatment. Measuring cerebral oxygenation is&#xD;
      a promising non-invasive way of cerebral monitoring in a neonatal intensive care unit. The&#xD;
      importance of cerebral monitoring in neonates with congenital heart problems at risk of&#xD;
      developing neurological complications is increasingly recognized. In this way the most&#xD;
      vulnerable moments for the newborn brain can be detected and ,if possible, lead to change in&#xD;
      (timing of) treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Neurodevelopmental follow up at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>Neurodevelopmental assessment at 24 months using Bayley scales of infant development II</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cerebrovascular changes in the transitional phase</measure>
    <time_frame>first 3 days of life</time_frame>
    <description>Cerebral oxygen saturation and autoregulatory capacity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association of cerebrovascular changes with short term outcome</measure>
    <time_frame>time frame of 1 admission</time_frame>
    <description>short term outcome defined as cerebral ultrasound abnormalities at admission and discharge, ICU stay, hospital stay and mortality before discharge</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">57</enrollment>
  <condition>Heart Defects, Congenital</condition>
  <arm_group>
    <arm_group_label>measuring cerebral oxygenation</arm_group_label>
    <description>NIRS: Measurement of cerebral oxygenation using Near Infrared Spectroscopy (NIRS) during the pre-operative phase in neonates with congenital heart disease.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>measuring cerebral oxygenation</intervention_name>
    <arm_group_label>measuring cerebral oxygenation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        infants with congenital heart defect&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  neonates with admission on neonatal intensive care unit with congenital heart disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No informed consent. (for the long term neurodevelopmental FU)&#xD;
&#xD;
          -  no cerebral oxygen saturation in the first 3 day's of life&#xD;
&#xD;
          -  gestational age &lt; 37 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>1 Month</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liesbeth Thewissen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Neonatal Intensive Care Unit UZLeuven</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>January 26, 2023</last_update_submitted>
  <last_update_submitted_qc>January 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heart Defects, congenital</keyword>
  <keyword>Patient Monitoring</keyword>
  <keyword>Infant, Newborn</keyword>
  <keyword>Physiology</keyword>
  <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>
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>April 14, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01679275
org study id: S54683
nct id: NCT01679275
lead sponsor: 
has dmc: No
Congenital heart disease with need for early surgery in newborns is associated with an
      increased incidence in global impairment in development. The causes of these late adverse
      neurologic outcomes are multifactoral and include both fixed (or patient-specific factors)
      and modifiable factors. They relate to both the mechanism of central nervous system injury
      associated with congenital heart disease and its treatment. Measuring cerebral oxygenation is
      a promising non-invasive way of cerebral monitoring in a neonatal intensive care unit. The
      importance of cerebral monitoring in neonates with congenital heart problems at risk of
      developing neurological complications is increasingly recognized. In this way the most
      vulnerable moments for the newborn brain can be detected and ,if possible, lead to change in
      (timing of) treatment.
observational model: Cohort
time perspective: Prospective
measure: Neurodevelopmental follow up at 24 months
time frame: 24 months
description: Neurodevelopmental assessment at 24 months using Bayley scales of infant development II
measure: cerebrovascular changes in the transitional phase
time frame: first 3 days of life
description: Cerebral oxygen saturation and autoregulatory capacity
measure: Association of cerebrovascular changes with short term outcome
time frame: time frame of 1 admission
description: short term outcome defined as cerebral ultrasound abnormalities at admission and discharge, ICU stay, hospital stay and mortality before discharge
arm group label: measuring cerebral oxygenation
description: NIRS: Measurement of cerebral oxygenation using Near Infrared Spectroscopy (NIRS) during the pre-operative phase in neonates with congenital heart disease.
intervention type: Other
intervention name: measuring cerebral oxygenation
arm group label: measuring cerebral oxygenation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 1 Month
healthy volunteers: No
last name: Liesbeth Thewissen, MD
role: Principal Investigator
affiliation: UZ Leuven
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
mesh term: Congenital Abnormalities
submitted: April 14, 2023