<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/NCT01665287</url>
  </required_header>
  <id_info>
    <org_study_id>300712FORVOS</org_study_id>
    <nct_id>NCT01665287</nct_id>
  </id_info>
  <brief_title>Cerebral Oximetry in Newborns - Comparing INVOS 5100 and FORE-SIGHT Cerebral Oximeters</brief_title>
  <official_title>Cerebral Oximetry in Newborns - Comparing INVOS 5100 and FORE-SIGHT Cerebral Oximeters Absolute Values, Sensitivity for Low Oxygen Levels and Reproducibility..</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Augustinus Foundation, Denmark.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Regional tissue oxygenation (rStO2) can be monitored by near infrared spectroscopy. The&#xD;
      commercial devices FORE-SIGHT (CASMED) and INVOS (COVIDIEN) will be used simultaneously to&#xD;
      test for their relative sensitivity for low oxygen levels just after birth on term infants&#xD;
      born by elective cesarean section. Reproducibility will be examined by replacements of the&#xD;
      sensors six times the next day when the infant is stable and quiet. Neonatal sensors will be&#xD;
      used.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cerebral oxygenation</measure>
    <time_frame>10 minutes</time_frame>
    <description>The sensors of both instruments will be placed on each side of the head. They will be held by hand or by self-adhesive tape as appropriate.&#xD;
Curve fitting will be used to describe the rapid increase of oxygenation after birth. Estimated cerebral oxygenation at 3 min (hypoxia) and 10 min (normoxia) will be used to compare the two instruments.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reproducibility</measure>
    <time_frame>10 minutes</time_frame>
    <description>The sensor will be placed 6 times alternating on each frontoparietal region and held by hand, obtaining 30 seconds of signal for each placement. The placements will be in the same region but not in exactly the same spot. This will be done for both devices.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Near Infrared Spectroscopy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Term infants born by elective cesarian section.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Term infants (age more than 37 weeks of gestation)&#xD;
&#xD;
          -  Elective cesarean section after an uncomplicated pregnancy&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Thick hair that makes good measurements difficult/impossible&#xD;
&#xD;
          -  Obvious malformations or syndrome&#xD;
&#xD;
          -  Complications in relation to the cesarean section&#xD;
&#xD;
          -  Depression after birth (APGAR &lt; 8 after 1 minute)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>2 Minutes</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gorm Greisen, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Not relevant</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Neonatology, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Noori S, Wlodaver A, Gottipati V, McCoy M, Schultz D, Escobedo M. Transitional changes in cardiac and cerebral hemodynamics in term neonates at birth. J Pediatr. 2012 Jun;160(6):943-8. doi: 10.1016/j.jpeds.2011.12.008. Epub 2012 Jan 11.</citation>
    <PMID>22244465</PMID>
  </reference>
  <reference>
    <citation>Kratky E, Pichler G, Rehak T, Avian A, Pocivalnik M, Muller W, Urlesberger B. Regional cerebral oxygen saturation in newborn infants in the first 15 min of life after vaginal delivery. Physiol Meas. 2012 Jan;33(1):95-102. doi: 10.1088/0967-3334/33/1/95.</citation>
    <PMID>22173332</PMID>
  </reference>
  <reference>
    <citation>Urlesberger B, Kratky E, Rehak T, Pocivalnik M, Avian A, Czihak J, Muller W, Pichler G. Regional oxygen saturation of the brain during birth transition of term infants: comparison between elective cesarean and vaginal deliveries. J Pediatr. 2011 Sep;159(3):404-8. doi: 10.1016/j.jpeds.2011.02.030. Epub 2011 Apr 9.</citation>
    <PMID>21481417</PMID>
  </reference>
  <reference>
    <citation>Urlesberger B, Grossauer K, Pocivalnik M, Avian A, Muller W, Pichler G. Regional oxygen saturation of the brain and peripheral tissue during birth transition of term infants. J Pediatr. 2010 Nov;157(5):740-4. doi: 10.1016/j.jpeds.2010.05.013. Epub 2010 Jun 17.</citation>
    <PMID>20955848</PMID>
  </reference>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>January 14, 2013</last_update_submitted>
  <last_update_submitted_qc>January 14, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 15, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Gorm Greisen</investigator_full_name>
    <investigator_title>Professor, MD</investigator_title>
  </responsible_party>
  <keyword>Cerebral Oximetry</keyword>
  <keyword>Near infrared spectroscopy</keyword>
  <keyword>Fullterm</keyword>
  <keyword>Infant</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/NCT01665287
org study id: 300712FORVOS
nct id: NCT01665287
lead sponsor: 
collaborator: 
has dmc: No
Regional tissue oxygenation (rStO2) can be monitored by near infrared spectroscopy. The
      commercial devices FORE-SIGHT (CASMED) and INVOS (COVIDIEN) will be used simultaneously to
      test for their relative sensitivity for low oxygen levels just after birth on term infants
      born by elective cesarean section. Reproducibility will be examined by replacements of the
      sensors six times the next day when the infant is stable and quiet. Neonatal sensors will be
      used.
observational model: Case-Only
time perspective: Prospective
measure: Cerebral oxygenation
time frame: 10 minutes
description: The sensors of both instruments will be placed on each side of the head. They will be held by hand or by self-adhesive tape as appropriate.
Curve fitting will be used to describe the rapid increase of oxygenation after birth. Estimated cerebral oxygenation at 3 min (hypoxia) and 10 min (normoxia) will be used to compare the two instruments.
measure: Reproducibility
time frame: 10 minutes
description: The sensor will be placed 6 times alternating on each frontoparietal region and held by hand, obtaining 30 seconds of signal for each placement. The placements will be in the same region but not in exactly the same spot. This will be done for both devices.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 2 Minutes
healthy volunteers: Accepts Healthy Volunteers
last name: Gorm Greisen, Professor
role: Principal Investigator
affiliation: Not relevant
facility: 
country: Denmark
citation: Noori S, Wlodaver A, Gottipati V, McCoy M, Schultz D, Escobedo M. Transitional changes in cardiac and cerebral hemodynamics in term neonates at birth. J Pediatr. 2012 Jun;160(6):943-8. doi: 10.1016/j.jpeds.2011.12.008. Epub 2012 Jan 11.
PMID: 22244465
citation: Kratky E, Pichler G, Rehak T, Avian A, Pocivalnik M, Muller W, Urlesberger B. Regional cerebral oxygen saturation in newborn infants in the first 15 min of life after vaginal delivery. Physiol Meas. 2012 Jan;33(1):95-102. doi: 10.1088/0967-3334/33/1/95.
PMID: 22173332
citation: Urlesberger B, Kratky E, Rehak T, Pocivalnik M, Avian A, Czihak J, Muller W, Pichler G. Regional oxygen saturation of the brain during birth transition of term infants: comparison between elective cesarean and vaginal deliveries. J Pediatr. 2011 Sep;159(3):404-8. doi: 10.1016/j.jpeds.2011.02.030. Epub 2011 Apr 9.
PMID: 21481417
citation: Urlesberger B, Grossauer K, Pocivalnik M, Avian A, Muller W, Pichler G. Regional oxygen saturation of the brain and peripheral tissue during birth transition of term infants. J Pediatr. 2010 Nov;157(5):740-4. doi: 10.1016/j.jpeds.2010.05.013. Epub 2010 Jun 17.
PMID: 20955848
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Gorm Greisen
investigator title: Professor, MD