<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/NCT03026192</url>
  </required_header>
  <id_info>
    <org_study_id>4585</org_study_id>
    <nct_id>NCT03026192</nct_id>
  </id_info>
  <brief_title>Near Infrared Spectroscopy to Determine Patent Ductus Arteriosus Closure</brief_title>
  <official_title>Use of Near Infrared Spectroscopy in Preterm Infants to Determine Patent Ductus Arteriosus Closure Following Medical Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albany Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Albany Medical College</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Using cerebral and renal near infrared spectroscopy monitoring to determine PDA closure in&#xD;
      preterm infants after completing medical treatment for a hemodynamically significant PDA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    not enough patients enrolled in study&#xD;
  </why_stopped>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Change in NIRS readings</measure>
    <time_frame>3 days</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">4</enrollment>
  <condition>Patent Ductus Arteriosus</condition>
  <arm_group>
    <arm_group_label>no PDA</arm_group_label>
    <description>These are infants who do not have a patent ductus arteriosus (PDA) as determine by echocardiography</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hsPDA</arm_group_label>
    <description>These are infants who have a hemodynamically significant PDA (hsPDA) as determined by echocardiography</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>near infrared spectroscopy</intervention_name>
    <description>Near infrared spectroscopy will be placed on infants both with and without hsPDA</description>
    <arm_group_label>hsPDA</arm_group_label>
    <arm_group_label>no PDA</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Preterm infants both with and without hsPDA. They will have NIRS monitors placed to measure&#xD;
        cerebral and renal regional tissue oxygenation. Those without a hsPDA will be monitored&#xD;
        solely around the time of initial echocardiogram. Those with a hsPDA will be monitored&#xD;
        around initial echocardiogram and the subsequent echocardiogram after treatment completion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  preterm infants less than 32 weeks gestation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  infection, congenital heart disease, syndromic anomalies, and perinatal asphyxia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Minute</minimum_age>
    <maximum_age>1 Week</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Albany Medical Center Neonatal Intesive Care Unit</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>January 18, 2019</last_update_submitted>
  <last_update_submitted_qc>January 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Albany Medical College</investigator_affiliation>
    <investigator_full_name>Kate Tauber</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ductus Arteriosus, Patent</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/NCT03026192
org study id: 4585
nct id: NCT03026192
lead sponsor: 
has dmc: Yes
Using cerebral and renal near infrared spectroscopy monitoring to determine PDA closure in
      preterm infants after completing medical treatment for a hemodynamically significant PDA.
observational model: Cohort
time perspective: Prospective
measure: Change in NIRS readings
time frame: 3 days
arm group label: no PDA
description: These are infants who do not have a patent ductus arteriosus (PDA) as determine by echocardiography
arm group label: hsPDA
description: These are infants who have a hemodynamically significant PDA (hsPDA) as determined by echocardiography
intervention type: Device
intervention name: near infrared spectroscopy
description: Near infrared spectroscopy will be placed on infants both with and without hsPDA
arm group label: hsPDA
arm group label: no PDA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Minute
maximum age: 1 Week
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Albany Medical College
investigator full name: Kate Tauber
investigator title: Assistant Professor
mesh term: Ductus Arteriosus, Patent
sharing ipd: No