<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/NCT01690650</url>
  </required_header>
  <id_info>
    <org_study_id>Oxygen - HH 527</org_study_id>
    <nct_id>NCT01690650</nct_id>
  </id_info>
  <brief_title>Neonatal Cerebral Oxygenation After Exposure to Oxygen Evaluated With the INVOS Oximeter</brief_title>
  <official_title>Oxygenation of the Neonatal Brain - a Study Using the INVOS Oximeter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Copenhagen University Hospital, Hvidovre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Ludvig &amp; Sara Elsass Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Copenhagen University Hospital, Hvidovre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Due to the increased risk of brain damage, continuous monitoring of the cerebral&#xD;
           oxygenation is interesting. The investigators will evaluate the capability of the INVOS&#xD;
           Oximeter to detect induced changes in the cerebral regional saturation.&#xD;
&#xD;
        -  The purpose of the study is to investigate our hypothesis that cerebral vasoconstriction&#xD;
           after oxygen exposure is prolonged in preterm infants compared to term infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preterm infants are at increased risk of brain damage compared with term infants, and&#xD;
      cerebral hypoxia is considered to have an important role. The preterm infants are at&#xD;
      increased risk of respiratory distress, episodes with low oxygenation, mechanical&#xD;
      ventilation, risk of hypocapnia and labile or low blood pressure. These conditions can affect&#xD;
      the microcirculation and hence the oxygenation of the brain. Hyperoxia is also a point of&#xD;
      interest, since high levels of oxygen can cause vasoconstriction.&#xD;
&#xD;
      The investigators will examine the normal physiological cerebral response to exposure of&#xD;
      oxygen in a group of preterm infants with a gestational age (GA) of 32-37 weeks and a group&#xD;
      of term infants.&#xD;
&#xD;
      The investigators will do dynamic research with continuously monitoring of the cerebral&#xD;
      oxygenation using the INVOS® Cerebral/Somatic Oximeter (Near InfraRed Spectroscopy (NIRS)).&#xD;
      Reproducibility is examined by repeated measurements.&#xD;
&#xD;
      There will be no follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline of cerebral oxygen saturation after oxygen exposure.</measure>
    <time_frame>Measurements will take between 30 minutes and 3 hours depending of situation. Measurements within the first 4 weeks of life. No follow-up.</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Response to Hyperoxia</condition>
  <arm_group>
    <arm_group_label>Oxygen + Cerebral NIRS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Induced changes in oxygen supply (100% vs. room air). Continuously monitoring of cerebral oxygen saturation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxygen</intervention_name>
    <description>Oxygen exposure (100% oxygen) for 5 minutes, then 25 minutes with room air. Repeated twice. Continuously monitoring of the cerebral oxygen saturation (NIRS).5 replacements of sensor for reproducibility.</description>
    <arm_group_label>Oxygen + Cerebral NIRS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newborns with a gestational age of 32-40 weeks&#xD;
&#xD;
          -  Clinically stable&#xD;
&#xD;
          -  +/- CPAP with a oxygen limit below 30%&#xD;
&#xD;
          -  Parental consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe birth asphyxia&#xD;
&#xD;
          -  Prohibition of oxygen exposure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Hour</minimum_age>
    <maximum_age>4 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ole Pryds, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Paediatrics, Copenhagen University Hospital, Hvidovre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Paediatrics, Copenhagen University Hospital; Hvidovre</name>
      <address>
        <city>Hvidovre</city>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>June 20, 2011</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>November 6, 2013</last_update_submitted>
  <last_update_submitted_qc>November 6, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 8, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Copenhagen University Hospital, Hvidovre</investigator_affiliation>
    <investigator_full_name>Line Carøe Sørensen</investigator_full_name>
    <investigator_title>MD, PH.D.</investigator_title>
  </responsible_party>
  <keyword>Preterm</keyword>
  <keyword>Newborn</keyword>
  <keyword>Neonate</keyword>
  <keyword>Cerebral oxygenation</keyword>
  <keyword>Oxygen</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperoxia</mesh_term>
  </condition_browse>
  <!-- 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/NCT01690650
org study id: Oxygen - HH 527
nct id: NCT01690650
lead sponsor: 
collaborator: 
has dmc: No
-  Due to the increased risk of brain damage, continuous monitoring of the cerebral
           oxygenation is interesting. The investigators will evaluate the capability of the INVOS
           Oximeter to detect induced changes in the cerebral regional saturation.

        -  The purpose of the study is to investigate our hypothesis that cerebral vasoconstriction
           after oxygen exposure is prolonged in preterm infants compared to term infants.
Preterm infants are at increased risk of brain damage compared with term infants, and
      cerebral hypoxia is considered to have an important role. The preterm infants are at
      increased risk of respiratory distress, episodes with low oxygenation, mechanical
      ventilation, risk of hypocapnia and labile or low blood pressure. These conditions can affect
      the microcirculation and hence the oxygenation of the brain. Hyperoxia is also a point of
      interest, since high levels of oxygen can cause vasoconstriction.

      The investigators will examine the normal physiological cerebral response to exposure of
      oxygen in a group of preterm infants with a gestational age (GA) of 32-37 weeks and a group
      of term infants.

      The investigators will do dynamic research with continuously monitoring of the cerebral
      oxygenation using the INVOS® Cerebral/Somatic Oximeter (Near InfraRed Spectroscopy (NIRS)).
      Reproducibility is examined by repeated measurements.

      There will be no follow-up.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Changes from baseline of cerebral oxygen saturation after oxygen exposure.
time frame: Measurements will take between 30 minutes and 3 hours depending of situation. Measurements within the first 4 weeks of life. No follow-up.
arm group label: Oxygen + Cerebral NIRS
arm group type: Experimental
description: Induced changes in oxygen supply (100% vs. room air). Continuously monitoring of cerebral oxygen saturation.
intervention type: Drug
intervention name: Oxygen
description: Oxygen exposure (100% oxygen) for 5 minutes, then 25 minutes with room air. Repeated twice. Continuously monitoring of the cerebral oxygen saturation (NIRS).5 replacements of sensor for reproducibility.
arm group label: Oxygen + Cerebral NIRS
criteria: 
gender: All
minimum age: 1 Hour
maximum age: 4 Weeks
healthy volunteers: No
last name: Ole Pryds, Professor
role: Principal Investigator
affiliation: Department of Paediatrics, Copenhagen University Hospital, Hvidovre
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Copenhagen University Hospital, Hvidovre
investigator full name: Line Carøe Sørensen
investigator title: MD, PH.D.
mesh term: Hyperoxia