<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/NCT04494217</url>
  </required_header>
  <id_info>
    <org_study_id>18815</org_study_id>
    <nct_id>NCT04494217</nct_id>
  </id_info>
  <brief_title>The Effect of Phototherapy Treatment on Oxygen Saturation Measurement in Newborns</brief_title>
  <official_title>The Influence of Phototherapy Lights on the Measurement of Oxygen Saturation With Pulse Oximeter in Newborns.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a prospective clinical study conducted with the approval of the Clinical&#xD;
      Research Ethics Committee.&#xD;
&#xD;
      The influence of phototherapy lights on the accuracy of pulse oximetry will be investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each patient's oxygen saturation will be measured non-invasively via a nondisposable&#xD;
      polyethylene neonatal probe taped to the infant's palm, toe, or dorsum of the foot. The probe&#xD;
      will be connected to an Massimo Rad97 pulse oximeter that is standardized at the factory. It&#xD;
      runs through an automatic systems check when turned on and needs no further calibration&#xD;
      before being used. The oxygen saturation measurements will be considered valid when there&#xD;
      will be a normal plethysmographic waveform, a fullscale signal strength bar, and a stable&#xD;
      heart rate closely approximating an independent electrocardiographic (ECG) pulse rate. The&#xD;
      pulse oximeter works by using the technology of plethsmography which allows the detection of&#xD;
      an arterial pulse) with oximetry (which measures oxygen saturation at specific wavelengths).&#xD;
      The pulse oximeter will be placed on each infant as already described. After a stable pulse&#xD;
      oximeter reading was obtained, the value will be recorded (&quot;before&quot;) and then the probe will&#xD;
      be covered with a standard disposable diaper, shiny side up. When the reading stabilized, the&#xD;
      value will be recorded (&quot;during&quot;) and then the diaper will be removed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">August 25, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 25, 2021</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>Percent Oxygen Saturation Before and During Covering Oximeter Probe</measure>
    <time_frame>The two data (''before'' and ''during'') will be recorded consecutively for each infant, when the reading stabilize. All measurements will be completed wiithin 6 months according to the study protocol calendar.</time_frame>
    <description>The two data points (percent oxygen saturation before and during covering of oximeter probe) for each patient will be compared.</description>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Hyperbilirubinemia, Neonatal Indirect</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All newborn babies who are receiving phototherapy for indirect hyperbilirubinemia in the&#xD;
        NICU of the Hacettepe University will be included in the study following the obtaining of&#xD;
        informed consent by their parents/guardian.&#xD;
&#xD;
        The oxygen saturation of all babies receiving inpatient treatment in the NICU is routinely&#xD;
        monitored with a pulse oximeter. In this study, the oxygen saturation of the newborns&#xD;
        receiving phototherapy will be recorded.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  newborn babies (0-28 days)&#xD;
&#xD;
          -  to be treated in the Hacettepe University Children's Hospital Neonatal Intensive Care&#xD;
             Unit&#xD;
&#xD;
          -  receiving phototherapy treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Newborn babies with any diseases that affect oxygen saturation including congenital&#xD;
             heart disease, chromosomal disease, inborn error of metabolism, anemia, circulatory&#xD;
             disorder, hypovolemia or hydrops fetalis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>28 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>İrem İyigün, MD</last_name>
    <phone>+905362428204</phone>
    <email>iiyigu07@hacettepe.edu.tr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>H Tolga Çelik, MD, Ass Prof</last_name>
    <phone>+905305925584</phone>
    <email>htcelik@gmail.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Vreman HJ, Wong RJ, Stevenson DK. Phototherapy: current methods and future directions. Semin Perinatol. 2004 Oct;28(5):326-33. doi: 10.1053/j.semperi.2004.09.003.</citation>
    <PMID>15686263</PMID>
  </reference>
  <reference>
    <citation>Zubrow AB, Henderson GW, Imaizumi SO, Pleasure JR. Pulse oximetry in sick premature infants and the effects of phototherapy and radiant warmers on the oxygen saturation readout. Am J Perinatol. 1990 Jan;7(1):75-8. doi: 10.1055/s-2007-999451.</citation>
    <PMID>2294914</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>H. Tolga Çelik</investigator_full_name>
    <investigator_title>MD, Assistant Professor in Neonatology</investigator_title>
  </responsible_party>
  <keyword>pulse oximeter, phototherapy, newborn</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperbilirubinemia, Neonatal</mesh_term>
    <mesh_term>Hyperbilirubinemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04494217
org study id: 18815
nct id: NCT04494217
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This will be a prospective clinical study conducted with the approval of the Clinical
      Research Ethics Committee.

      The influence of phototherapy lights on the accuracy of pulse oximetry will be investigated.
Each patient's oxygen saturation will be measured non-invasively via a nondisposable
      polyethylene neonatal probe taped to the infant's palm, toe, or dorsum of the foot. The probe
      will be connected to an Massimo Rad97 pulse oximeter that is standardized at the factory. It
      runs through an automatic systems check when turned on and needs no further calibration
      before being used. The oxygen saturation measurements will be considered valid when there
      will be a normal plethysmographic waveform, a fullscale signal strength bar, and a stable
      heart rate closely approximating an independent electrocardiographic (ECG) pulse rate. The
      pulse oximeter works by using the technology of plethsmography which allows the detection of
      an arterial pulse) with oximetry (which measures oxygen saturation at specific wavelengths).
      The pulse oximeter will be placed on each infant as already described. After a stable pulse
      oximeter reading was obtained, the value will be recorded ("before") and then the probe will
      be covered with a standard disposable diaper, shiny side up. When the reading stabilized, the
      value will be recorded ("during") and then the diaper will be removed.
observational model: Cohort
time perspective: Prospective
measure: Percent Oxygen Saturation Before and During Covering Oximeter Probe
time frame: The two data (''before'' and ''during'') will be recorded consecutively for each infant, when the reading stabilize. All measurements will be completed wiithin 6 months according to the study protocol calendar.
description: The two data points (percent oxygen saturation before and during covering of oximeter probe) for each patient will be compared.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 28 Days
healthy volunteers: No
last name: İrem İyigün, MD
phone: +905362428204
email: iiyigu07@hacettepe.edu.tr
last name: H Tolga Çelik, MD, Ass Prof
phone: +905305925584
email: htcelik@gmail.com
citation: Vreman HJ, Wong RJ, Stevenson DK. Phototherapy: current methods and future directions. Semin Perinatol. 2004 Oct;28(5):326-33. doi: 10.1053/j.semperi.2004.09.003.
PMID: 15686263
citation: Zubrow AB, Henderson GW, Imaizumi SO, Pleasure JR. Pulse oximetry in sick premature infants and the effects of phototherapy and radiant warmers on the oxygen saturation readout. Am J Perinatol. 1990 Jan;7(1):75-8. doi: 10.1055/s-2007-999451.
PMID: 2294914
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: H. Tolga Çelik
investigator title: MD, Assistant Professor in Neonatology
mesh term: Hyperbilirubinemia, Neonatal
mesh term: Hyperbilirubinemia
sharing ipd: No