<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/NCT03798093</url>
  </required_header>
  <id_info>
    <org_study_id>MINVI Echo Study</org_study_id>
    <nct_id>NCT03798093</nct_id>
  </id_info>
  <brief_title>MINVI Echocardiography Sub-Study</brief_title>
  <official_title>Echocardiography Substudy of the Umbilical Cord Milking in Non Vigorous Infants Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sharp HealthCare</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sharp Mary Birch Hospital for Women &amp; Newborns</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sharp HealthCare</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Non-vigorous infants enrolled in the MINVI trial will be approached for consent for ongoing&#xD;
      data collection. As part of the data collection, an optional echocardiogram will be performed&#xD;
      if the parent consents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-vigorous infants enrolled in the MINVI trial will be approached for consent for ongoing&#xD;
      data collection. As part of the data collection, an optional echocardiogram will be performed&#xD;
      if the parent consents. The consent will have a check box to indicate if they consent to the&#xD;
      additional test.&#xD;
&#xD;
      Echocardiographic measurements will be performed on all infants at 12 hours +/-3 hours of age&#xD;
      by our research sonographers who are blinded to infant randomization. Measurements will be&#xD;
      taken according to a standard operating procedure to assess systemic blood flow, by superior&#xD;
      vena cava (SVC) flow (ml/kg/min), right ventricular output (ml/kg/min), left ventricular&#xD;
      output (LVO) (ml/kg/min), measures of left and right venitricular tissue Doppler and strain&#xD;
      imaging. These measurements will be performed off line at a later time. Data will be entered&#xD;
      into REDCap.&#xD;
&#xD;
      If any structural abnormalities are found, the attending pediatrician will be notified of the&#xD;
      abnormal echocardiogram. The consent will clearly state that this echo is not for diagnostic&#xD;
      purposes. Any additional studies including an official complete echocardiogram and or&#xD;
      cardiology consultation will be left to the discretion of the attending pediatrician, as&#xD;
      he/she deems necessary&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">June 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Cluster Randomized Crossover</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac Output</measure>
    <time_frame>12 +/- 6 hours of life</time_frame>
    <description>Cardiac Output measured by Left Ventricular Output</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Right Ventricular Output</measure>
    <time_frame>12 +/- 6 hours of life</time_frame>
    <description>Obtained from the modified short axis view of Cardiac Ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SVC Flow</measure>
    <time_frame>12 +/- 6 hours of life</time_frame>
    <description>SVC flow (Diameter obtained from the infaclavicular view (hybrid view), Doppler from the subcostal view)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Systolic Strain and Strain rate</measure>
    <time_frame>12 +/- 6 hours of life</time_frame>
    <description>Measures of Left and Right Ventricular Strain and Strain rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Systolic Tissue Doppler</measure>
    <time_frame>12 +/- 6 hours of life</time_frame>
    <description>Measure of left and right ventricular peak systolic Tissue Doppler velocity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Birth Asphyxia</condition>
  <arm_group>
    <arm_group_label>Umbilical Cord Milking</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk the entire length of umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for ECC as we have demonstrated in our previous trials.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early Cord Clamping</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This will occur by clamping the umbilical cord as soon as possible. Since both ECC and UCM will occur after a brief assessment, it is important to note that the cord clamping time will be longer than in previously conducted preterm trials (average 20 seconds) which performed the intervention on all subjects regardless of whether or not they were vigorous. In all cases, the cord clamping time will be documented to ensure consistency.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Umbilical Cord Milking</intervention_name>
    <description>At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds.</description>
    <arm_group_label>Umbilical Cord Milking</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Early Cord Clamping</intervention_name>
    <description>The umbilical cord is clamped within 30 seconds of delivery.</description>
    <arm_group_label>Early Cord Clamping</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Non-vigorous newborns born between 35-42 weeks gestation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Known major congenital or chromosomal anomalies of newborn Known cardiac defects other than&#xD;
        small ASD, VSD and PDA Complete placental abruption/cutting through the placenta at time of&#xD;
        delivery Monochorionic multiples Cord Avulsion Presence of non-reducible nuchal cord&#xD;
        Perinatal providers unaware of the protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Weeks</minimum_age>
    <maximum_age>42 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anup Katheria, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sharp Mary Birch Hospital for Women &amp; Newborns</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>September 2023</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2023</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, Neonatal Research Institute</investigator_title>
  </responsible_party>
  <keyword>Umbilical Cord Milking</keyword>
  <keyword>Immediate Cord Clamping</keyword>
  <keyword>Resuscitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asphyxia Neonatorum</mesh_term>
    <mesh_term>Asphyxia</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/NCT03798093
org study id: MINVI Echo Study
nct id: NCT03798093
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Non-vigorous infants enrolled in the MINVI trial will be approached for consent for ongoing
      data collection. As part of the data collection, an optional echocardiogram will be performed
      if the parent consents.
Non-vigorous infants enrolled in the MINVI trial will be approached for consent for ongoing
      data collection. As part of the data collection, an optional echocardiogram will be performed
      if the parent consents. The consent will have a check box to indicate if they consent to the
      additional test.

      Echocardiographic measurements will be performed on all infants at 12 hours +/-3 hours of age
      by our research sonographers who are blinded to infant randomization. Measurements will be
      taken according to a standard operating procedure to assess systemic blood flow, by superior
      vena cava (SVC) flow (ml/kg/min), right ventricular output (ml/kg/min), left ventricular
      output (LVO) (ml/kg/min), measures of left and right venitricular tissue Doppler and strain
      imaging. These measurements will be performed off line at a later time. Data will be entered
      into REDCap.

      If any structural abnormalities are found, the attending pediatrician will be notified of the
      abnormal echocardiogram. The consent will clearly state that this echo is not for diagnostic
      purposes. Any additional studies including an official complete echocardiogram and or
      cardiology consultation will be left to the discretion of the attending pediatrician, as
      he/she deems necessary
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Cluster Randomized Crossover
primary purpose: Diagnostic
masking: None (Open Label)
measure: Cardiac Output
time frame: 12 +/- 6 hours of life
description: Cardiac Output measured by Left Ventricular Output
measure: Right Ventricular Output
time frame: 12 +/- 6 hours of life
description: Obtained from the modified short axis view of Cardiac Ultrasound
measure: SVC Flow
time frame: 12 +/- 6 hours of life
description: SVC flow (Diameter obtained from the infaclavicular view (hybrid view), Doppler from the subcostal view)
measure: Peak Systolic Strain and Strain rate
time frame: 12 +/- 6 hours of life
description: Measures of Left and Right Ventricular Strain and Strain rate
measure: Peak Systolic Tissue Doppler
time frame: 12 +/- 6 hours of life
description: Measure of left and right ventricular peak systolic Tissue Doppler velocity
arm group label: Umbilical Cord Milking
arm group type: Active Comparator
description: The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk the entire length of umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for ECC as we have demonstrated in our previous trials.
arm group label: Early Cord Clamping
arm group type: Active Comparator
description: This will occur by clamping the umbilical cord as soon as possible. Since both ECC and UCM will occur after a brief assessment, it is important to note that the cord clamping time will be longer than in previously conducted preterm trials (average 20 seconds) which performed the intervention on all subjects regardless of whether or not they were vigorous. In all cases, the cord clamping time will be documented to ensure consistency.
intervention type: Procedure
intervention name: Umbilical Cord Milking
description: At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds.
arm group label: Umbilical Cord Milking
intervention type: Procedure
intervention name: Early Cord Clamping
description: The umbilical cord is clamped within 30 seconds of delivery.
arm group label: Early Cord Clamping
criteria: 
gender: All
minimum age: 35 Weeks
maximum age: 42 Weeks
healthy volunteers: No
last name: Anup Katheria, MD
role: Principal Investigator
affiliation: Sharp Mary Birch Hospital for Women & Newborns
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Sharp HealthCare
investigator full name: Anup Katheria, M.D.
investigator title: Director, Neonatal Research Institute
mesh term: Asphyxia Neonatorum
mesh term: Asphyxia
sharing ipd: No