<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/NCT02231411</url>
  </required_header>
  <id_info>
    <org_study_id>NRIC</org_study_id>
    <secondary_id>5R21HD080594</secondary_id>
    <nct_id>NCT02231411</nct_id>
  </id_info>
  <brief_title>Neonatal Resuscitation With Intact Cord</brief_title>
  <acronym>NRIC</acronym>
  <official_title>Neonatal Resuscitation With Intact Cord</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sharp HealthCare</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Sharp HealthCare</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine whether providing ventilation during delayed&#xD;
      umbilical cord clamping provides greater placental transfusion and improved hemodynamic&#xD;
      transition at birth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will receive 1 minute of delayed cord clamping in both arms. One arm will receive&#xD;
      routine care, warm dry and stimulate during the 1 minutes transfusion. The second arm will&#xD;
      receive routine care PLUS administration of CPAP and if need positive pressure ventilation.&#xD;
      The outcome is to determine whether the addition of ventilation provides a larger placental&#xD;
      transfusion and a smoother transition at birth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Hematocrit</measure>
    <time_frame>within 24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum inspired oxygen (FiO2) (percentage)</measure>
    <time_frame>over the first 5 minutes of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive Pressure Ventilation given</measure>
    <time_frame>1 minute</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DR interventions after delayed cord clamping complete</measure>
    <time_frame>10 minutes of life</time_frame>
    <description>PPV, CPAP, intubation, chest compressions, volume, medications (yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Peak Inspiratory Pressure (cm H2O)</measure>
    <time_frame>over the first 5 minutes of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach heart rate &gt;100 beats per minute (seconds)</measure>
    <time_frame>over the first 5 minutes of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time oxygen saturation within and outside of target range (seconds)</measure>
    <time_frame>over the first 5 minutes of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of the resuscitation (minutes)</measure>
    <time_frame>up to 30 minutes of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to demonstrate cycling of end tidal CO2 (seconds)</measure>
    <time_frame>First minute of life</time_frame>
    <description>Evaluated by analysis of video recording</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum End Tidal CO2 (mm Hg)</measure>
    <time_frame>up to 30 minutes of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intubation (yes/no) in DR/NICU and age (hours)</measure>
    <time_frame>up to 7 days of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surfactant (yes/no) in DR/NICU and age (hours)</measure>
    <time_frame>up to 7 days of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SVC Flow (ml/kg/min)</measure>
    <time_frame>target time 6 hours of life</time_frame>
    <description>plus/minus 6 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right ventricular output (ml/kg/min)</measure>
    <time_frame>6 hours of life</time_frame>
    <description>plus/minus 6 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac Output by Electrical Cardiometry (ml/kg/min)</measure>
    <time_frame>over the first 24 hours of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral StO2 by Near-Infrared Spectroscopy</measure>
    <time_frame>over the first 24 hours of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fractional Oxygen Extraction by Near-Infrared Spectroscopy</measure>
    <time_frame>24 hours of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Color Doppler diameter of ductus arteriosus shunt (mm)</measure>
    <time_frame>6 hours of life</time_frame>
    <description>plus/minus 6 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulsed or continuous wave Doppler assessment of ductus arteriosus shunt direction (%time right to left) and velocity (m/s)</measure>
    <time_frame>6 hours of life</time_frame>
    <description>plus/minus 6 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Color Doppler diameter of inter-atrial shunt (mm)</measure>
    <time_frame>6 hours of life</time_frame>
    <description>plus/minus 6 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulsed and continuous wave Doppler assessment of inter-atrial shunt direction (% time right to left) and velocity (m/s)</measure>
    <time_frame>6 hours of life</time_frame>
    <description>plus/minus 6 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak velocity of the tricuspid regurgitation jet (m/sec) (to calculate arterial pressure)</measure>
    <time_frame>6 hours of life</time_frame>
    <description>plus/minus 6 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Record Blood pressure (SBP/DBP, MAP) and whether hypotensive (defined as &lt; GA on DOL 1) yes/no</measure>
    <time_frame>over the first 6 hours of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial and venous cord pH</measure>
    <time_frame>at birth (first minute of life)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak total serum bilirubin (mg/dL)</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of phototherapy days</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum hematocrit</measure>
    <time_frame>at birth, 12 hours, and 30 days of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Admission temperatures (degree Centigrade)</measure>
    <time_frame>within 1 hour of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine output (ml/kg/day)</measure>
    <time_frame>over the first 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Arterial Blood pressure (mm Hg)</measure>
    <time_frame>over the first 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of cardiac inotropes (dopamine, dobutamine, epinephrine) (yes/no) hypotension</measure>
    <time_frame>over the first 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of postnatal steroids (yes/no)</measure>
    <time_frame>4 months or until hospital discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of intraventricular hemorrhage (yes/no)</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of severe intraventricular hemorrhage (Grade 3 or 4) (yes/no)</measure>
    <time_frame>4 months or until hospital discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of PVL (yes/no)</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality (yes/no)</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Placental Weight</measure>
    <time_frame>weighed within 24 hours of delivery of the infant</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal Hemoglobin</measure>
    <time_frame>in the first 48 hours post delivery of the infant</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Airway Pressure (MAP)</measure>
    <time_frame>First 5 minutes of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of CPAP or PPV</measure>
    <time_frame>First one minute of life</time_frame>
    <description>Evaluated by analysis of video recording</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of umbilical cord allows use of LifeStart bed</measure>
    <time_frame>First one minute of life</time_frame>
    <description>Evaluated by analysis of video recording</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Intraventricular Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Ventilation during DCC (V-DCC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Measuring the volume of placental transfusion with ventilation (CPAP 5 cm H2O between inflations) in infants born by C/S or VG using, as an initial surrogate marker, Hematocrits at 12 hours of life (HOL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DCC plus dry and stimulate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Measuring the volume of placental transfusions with delayed cord clamping alone (DCC) in infants born by C/S or VD using, as an initial surrogate marker, Hematocrits at 12 hours of life (HOL)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>V-DCC</intervention_name>
    <description>Ventilation with CPAP 5 cm H2O between inflations and Delayed clamping of the umbilical cord for 60 seconds</description>
    <arm_group_label>Ventilation during DCC (V-DCC)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Delayed cord clamping</intervention_name>
    <description>Delayed clamping of the umbilical cord for 60 seconds</description>
    <arm_group_label>DCC plus dry and stimulate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels</intervention_name>
    <arm_group_label>DCC plus dry and stimulate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational Age: Women admitted 23+0 to 31+6 weeks (Reason: Highest risk for IVH)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gestational Age: Parents decline consent (Reason: Can only perform intervention at&#xD;
             time of delivery)&#xD;
&#xD;
          -  Congenital anomalies of newborn (Reason: Exclude the effect of abnormal hematological&#xD;
             function)&#xD;
&#xD;
          -  Placental abruption (Reason: Exclude pregnancies at risk for hemorrhage at the time of&#xD;
             delivery)&#xD;
&#xD;
          -  Twin to twin transfusion (Reason: Exclude possible loss of blood from other twin&#xD;
             during delayed cord clamping)&#xD;
&#xD;
          -  Placenta Accreta&#xD;
&#xD;
          -  Prolonged premature rupture of membranes (&gt; 2 weeks) prior to 23 weeks gestation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>23 Weeks</minimum_age>
    <maximum_age>31 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anup C 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>May 2017</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>May 24, 2017</last_update_submitted>
  <last_update_submitted_qc>May 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2017</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>Delayed Cord Clamping</keyword>
  <keyword>Pulmonary Ventilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</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/NCT02231411
org study id: NRIC
secondary id: 5R21HD080594
nct id: NCT02231411
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to examine whether providing ventilation during delayed
      umbilical cord clamping provides greater placental transfusion and improved hemodynamic
      transition at birth.
Subjects will receive 1 minute of delayed cord clamping in both arms. One arm will receive
      routine care, warm dry and stimulate during the 1 minutes transfusion. The second arm will
      receive routine care PLUS administration of CPAP and if need positive pressure ventilation.
      The outcome is to determine whether the addition of ventilation provides a larger placental
      transfusion and a smoother transition at birth.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Care Provider)
measure: Peak Hematocrit
time frame: within 24 hours
measure: Maximum inspired oxygen (FiO2) (percentage)
time frame: over the first 5 minutes of life
measure: Positive Pressure Ventilation given
time frame: 1 minute
measure: DR interventions after delayed cord clamping complete
time frame: 10 minutes of life
description: PPV, CPAP, intubation, chest compressions, volume, medications (yes/no)
measure: Maximum Peak Inspiratory Pressure (cm H2O)
time frame: over the first 5 minutes of life
measure: Time to reach heart rate >100 beats per minute (seconds)
time frame: over the first 5 minutes of life
measure: Time oxygen saturation within and outside of target range (seconds)
time frame: over the first 5 minutes of life
measure: Time of the resuscitation (minutes)
time frame: up to 30 minutes of life
measure: Time to demonstrate cycling of end tidal CO2 (seconds)
time frame: First minute of life
description: Evaluated by analysis of video recording
measure: Maximum End Tidal CO2 (mm Hg)
time frame: up to 30 minutes of life
measure: Intubation (yes/no) in DR/NICU and age (hours)
time frame: up to 7 days of life
measure: Surfactant (yes/no) in DR/NICU and age (hours)
time frame: up to 7 days of life
measure: SVC Flow (ml/kg/min)
time frame: target time 6 hours of life
description: plus/minus 6 hours
measure: Right ventricular output (ml/kg/min)
time frame: 6 hours of life
description: plus/minus 6 hours
measure: Cardiac Output by Electrical Cardiometry (ml/kg/min)
time frame: over the first 24 hours of life
measure: Cerebral StO2 by Near-Infrared Spectroscopy
time frame: over the first 24 hours of life
measure: Fractional Oxygen Extraction by Near-Infrared Spectroscopy
time frame: 24 hours of life
measure: Color Doppler diameter of ductus arteriosus shunt (mm)
time frame: 6 hours of life
description: plus/minus 6 hours
measure: Pulsed or continuous wave Doppler assessment of ductus arteriosus shunt direction (%time right to left) and velocity (m/s)
time frame: 6 hours of life
description: plus/minus 6 hours
measure: Color Doppler diameter of inter-atrial shunt (mm)
time frame: 6 hours of life
description: plus/minus 6 hours
measure: Pulsed and continuous wave Doppler assessment of inter-atrial shunt direction (% time right to left) and velocity (m/s)
time frame: 6 hours of life
description: plus/minus 6 hours
measure: Peak velocity of the tricuspid regurgitation jet (m/sec) (to calculate arterial pressure)
time frame: 6 hours of life
description: plus/minus 6 hours
measure: Record Blood pressure (SBP/DBP, MAP) and whether hypotensive (defined as < GA on DOL 1) yes/no
time frame: over the first 6 hours of life
measure: Arterial and venous cord pH
time frame: at birth (first minute of life)
measure: Peak total serum bilirubin (mg/dL)
time frame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
measure: Duration of phototherapy days
time frame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
measure: Serum hematocrit
time frame: at birth, 12 hours, and 30 days of life
measure: Admission temperatures (degree Centigrade)
time frame: within 1 hour of life
measure: Urine output (ml/kg/day)
time frame: over the first 72 hours
measure: Mean Arterial Blood pressure (mm Hg)
time frame: over the first 24 hours
measure: Use of cardiac inotropes (dopamine, dobutamine, epinephrine) (yes/no) hypotension
time frame: over the first 72 hours
measure: Use of postnatal steroids (yes/no)
time frame: 4 months or until hospital discharge
measure: Presence of intraventricular hemorrhage (yes/no)
time frame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
measure: Presence of severe intraventricular hemorrhage (Grade 3 or 4) (yes/no)
time frame: 4 months or until hospital discharge
measure: Presence of PVL (yes/no)
time frame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
measure: Mortality (yes/no)
time frame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
measure: Placental Weight
time frame: weighed within 24 hours of delivery of the infant
measure: Maternal Hemoglobin
time frame: in the first 48 hours post delivery of the infant
measure: Mean Airway Pressure (MAP)
time frame: First 5 minutes of life
measure: Duration of CPAP or PPV
time frame: First one minute of life
description: Evaluated by analysis of video recording
measure: Length of umbilical cord allows use of LifeStart bed
time frame: First one minute of life
description: Evaluated by analysis of video recording
arm group label: Ventilation during DCC (V-DCC)
arm group type: Active Comparator
description: Measuring the volume of placental transfusion with ventilation (CPAP 5 cm H2O between inflations) in infants born by C/S or VG using, as an initial surrogate marker, Hematocrits at 12 hours of life (HOL)
arm group label: DCC plus dry and stimulate
arm group type: Active Comparator
description: Measuring the volume of placental transfusions with delayed cord clamping alone (DCC) in infants born by C/S or VD using, as an initial surrogate marker, Hematocrits at 12 hours of life (HOL)
intervention type: Procedure
intervention name: V-DCC
description: Ventilation with CPAP 5 cm H2O between inflations and Delayed clamping of the umbilical cord for 60 seconds
arm group label: Ventilation during DCC (V-DCC)
intervention type: Procedure
intervention name: Delayed cord clamping
description: Delayed clamping of the umbilical cord for 60 seconds
arm group label: DCC plus dry and stimulate
intervention type: Procedure
intervention name: Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels
arm group label: DCC plus dry and stimulate
criteria: 
gender: All
minimum age: 23 Weeks
maximum age: 31 Weeks
healthy volunteers: No
last name: Anup C 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 Neonatal Research Institute
mesh term: Hemorrhage