<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/NCT02195037</url>
  </required_header>
  <id_info>
    <org_study_id>CO-DCC</org_study_id>
    <nct_id>NCT02195037</nct_id>
  </id_info>
  <brief_title>Changes in Cardiac Output During Delayed Umbilical Cord Clamping</brief_title>
  <official_title>Changes in Cardiac Output During Delayed Umbilical Cord Clamping</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sharp HealthCare</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sharp HealthCare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recently, the American College of Obstetricians and Gynecologists (ACOG) recommended a delay&#xD;
      of 30-60 seconds in umbilical cord clamping for all newborn infants. This delay allows the&#xD;
      newborn to receive his/her own blood from the placenta (placental transfusion) which helps&#xD;
      their transition in the first hours of life. The purpose of the study is to learn about the&#xD;
      amount of blood flow to and from the baby's heart during normal newborn transition&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Cardiac Output</measure>
    <time_frame>5 minutes of Life</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stroke Volume</measure>
    <time_frame>5 Minutes of Life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bilirubin level</measure>
    <time_frame>until discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin level</measure>
    <time_frame>until discharge</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Cardiac Output, Low</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy full term infants delivered by vaginal birth with an estimated gestational age of&#xD;
        37+1 to 41+6 weeks corrected gestational age&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy full term infants&#xD;
&#xD;
          -  Delivered by vaginal birth&#xD;
&#xD;
          -  Estimated gestational age of 37+0to 41+6 weeks corrected gestational age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiples&#xD;
&#xD;
          -  Known fetal anomalies (including cardiac defects).&#xD;
&#xD;
          -  Instrumentation during delivery (forceps or vacuum)&#xD;
&#xD;
          -  Non-reducible nuchal cord during delivery.&#xD;
&#xD;
          -  Any maternal or neonatal indication requiring immediate cord clamping.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>1 Minute</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anup Katheria, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sharp HealthCare</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sharp Mary Birch Hospital for Women and Newborns</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>May 18, 2015</last_update_submitted>
  <last_update_submitted_qc>May 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sharp HealthCare</investigator_affiliation>
    <investigator_full_name>Anup Katheria, M.D.</investigator_full_name>
    <investigator_title>Director of Neonatal Research</investigator_title>
  </responsible_party>
  <keyword>Delayed Cord Clamping</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiac Output, Low</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/NCT02195037
org study id: CO-DCC
nct id: NCT02195037
lead sponsor: 
has dmc: No
Recently, the American College of Obstetricians and Gynecologists (ACOG) recommended a delay
      of 30-60 seconds in umbilical cord clamping for all newborn infants. This delay allows the
      newborn to receive his/her own blood from the placenta (placental transfusion) which helps
      their transition in the first hours of life. The purpose of the study is to learn about the
      amount of blood flow to and from the baby's heart during normal newborn transition
observational model: Cohort
time perspective: Prospective
measure: Cardiac Output
time frame: 5 minutes of Life
measure: Stroke Volume
time frame: 5 Minutes of Life
measure: Bilirubin level
time frame: until discharge
measure: Hemoglobin level
time frame: until discharge
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 1 Minute
healthy volunteers: No
last name: Anup Katheria, MD
role: Principal Investigator
affiliation: Sharp HealthCare
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Sharp HealthCare
investigator full name: Anup Katheria, M.D.
investigator title: Director of Neonatal Research
mesh term: Cardiac Output, Low