<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/NCT01684618</url>
  </required_header>
  <id_info>
    <org_study_id>CPAP - HH 527</org_study_id>
    <nct_id>NCT01684618</nct_id>
  </id_info>
  <brief_title>Neonatal Cerebral Oxygenation and Changes in CPAP Flow Pressure - Evaluation With 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. We will evaluate the capability of the INVOS Oximeter to&#xD;
           detect induced changes in the cerebral regional saturation.&#xD;
&#xD;
        -  The purpose of the study is to investigate our hypothesis that a particular CPAP flow&#xD;
           pressure optimizes the regional cerebral oxygenation.&#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. Preterm infants is often&#xD;
      treated with CPAP (Continuous positive airway pressure), but the effect of different flow&#xD;
      pressures on the regional cerebral oxygenation is not known.&#xD;
&#xD;
      The investigators will examine the normal physiological response of the brain in a group of&#xD;
      preterm infants with a gestational age (GA) of 32-37 weeks and a group of term infants to the&#xD;
      commonly used treatment in neonatology, CPAP (Continuous positive airway pressure).&#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;
      INVOS® is the first NIRS-based oximeter CE-approved for hospital use in Denmark.&#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 in regional cerebral oxygen saturation, rSO2, during induced changes in CPAP flow pressure</measure>
    <time_frame>Measurements will take between 30 minutes and 3 hours depending of situation. Within the first 4 weeks of life.</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Cerebral Oxygenation</condition>
  <arm_group>
    <arm_group_label>Cerebral NIRS oximetry + CPAP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cerebral NIRS oximetry, using the INVOS Cerebral/Somatic Oximeter, and changes in regional cerebral oxygen saturation, rSO2, during induced changes in CPAP flow pressure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cerebral NIRS Oximetry + CPAP</intervention_name>
    <description>CPAP flow pressure is increased for 5 minutes then 15 minutes with CPAP pressure at baseline. Repeated once</description>
    <arm_group_label>Cerebral NIRS oximetry + CPAP</arm_group_label>
    <other_name>INVOS 5100C Oximeter</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion Criteria: - Newborns with a gestational age of 32-40 weeks - Clinically&#xD;
             stable - +/- CPAP with a oxygen limit below 30% - Parental consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe birth asphyxia - 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>
  <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>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 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>Neonate</keyword>
  <keyword>Newborn</keyword>
  <keyword>Cerebral oxygenation</keyword>
  <keyword>CPAP</keyword>
  <!-- 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/NCT01684618
org study id: CPAP - HH 527
nct id: NCT01684618
lead sponsor: 
collaborator: 
has dmc: No
-  Due to the increased risk of brain damage, continuous monitoring of the cerebral
           oxygenation is interesting. We 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 a particular CPAP flow
           pressure optimizes the regional cerebral oxygenation.
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. Preterm infants is often
      treated with CPAP (Continuous positive airway pressure), but the effect of different flow
      pressures on the regional cerebral oxygenation is not known.

      The investigators will examine the normal physiological response of the brain in a group of
      preterm infants with a gestational age (GA) of 32-37 weeks and a group of term infants to the
      commonly used treatment in neonatology, CPAP (Continuous positive airway pressure).

      The investigators will do dynamic research with continuously monitoring of the cerebral
      oxygenation using the INVOS® Cerebral/Somatic Oximeter (Near InfraRed Spectroscopy (NIRS)).
      INVOS® is the first NIRS-based oximeter CE-approved for hospital use in Denmark.

      There will be no follow-up.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Changes in regional cerebral oxygen saturation, rSO2, during induced changes in CPAP flow pressure
time frame: Measurements will take between 30 minutes and 3 hours depending of situation. Within the first 4 weeks of life.
arm group label: Cerebral NIRS oximetry + CPAP
arm group type: Experimental
description: Cerebral NIRS oximetry, using the INVOS Cerebral/Somatic Oximeter, and changes in regional cerebral oxygen saturation, rSO2, during induced changes in CPAP flow pressure
intervention type: Procedure
intervention name: Cerebral NIRS Oximetry + CPAP
description: CPAP flow pressure is increased for 5 minutes then 15 minutes with CPAP pressure at baseline. Repeated once
arm group label: Cerebral NIRS oximetry + CPAP
other name: INVOS 5100C Oximeter
criteria: 
gender: All
minimum age: 1 Hour
maximum age: 4 Weeks
healthy volunteers: No
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.