<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/NCT04413097</url>
  </required_header>
  <id_info>
    <org_study_id>DOXIE</org_study_id>
    <nct_id>NCT04413097</nct_id>
  </id_info>
  <brief_title>Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants</brief_title>
  <acronym>DOXIE</acronym>
  <official_title>Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants</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>
    <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>
      This study is being conducted to compare the incidence of preterm infants (up to 28+6 weeks&#xD;
      GA) who achieve a peripheral oxygen saturation of 80 percent by 5 minutes of life (MOL) given&#xD;
      mask CPAP/PPV with an FiO2 of 1.0 during DCC for 90 seconds (HI Group) to infants given mask&#xD;
      CPAP/PPV with an FiO2 of .30 during DCC for 90 seconds (LO Group).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prenatal consent will be obtained on infant's with estimated gestational age up to 28+6&#xD;
      weeks. Shortly before delivery, infant's will be randomly assigned to receive either Low&#xD;
      oxygen concentration (FiO2 .30) OR High oxygen concentration (FiO2 1.0) during 90 seconds of&#xD;
      delayed cord clamping.&#xD;
&#xD;
      Randomization and intervention will remain blinded to the clinical care team during the&#xD;
      entire study period. The research team member will open a randomization card when notified of&#xD;
      a subject's impending birth, review the protocol with the obstetric provider performing the&#xD;
      procedure, set-up the sterile stabilization bed, and note the time it takes from delivery&#xD;
      until the clamping and cutting of the umbilical cord in both groups.&#xD;
&#xD;
      The research team member will set the oxygen blender as indicated by the randomization card&#xD;
      and cover the blender to blind the FiO2 setting. The research team member will not be&#xD;
      involved in the clinical care of the infant. The oxygen blender will be concealed from the&#xD;
      clinical care team to ensure resuscitation maneuvers will not be biased.&#xD;
&#xD;
      Data will be submitted to the statistician, who will remain blinded to the intervention for&#xD;
      the duration of the study.&#xD;
&#xD;
      At delivery, the infant will be placed on a platform that allows the infant to be close to&#xD;
      the mother and the umbilical cord to remain intact for DCC. These beds are equipped with an&#xD;
      oxygen blender, humidifier, t-piece resuscitator with mask, necessary to provide CPAP/PPV. At&#xD;
      some centers the bed will be equipped with a radian warmer (Ceramotherm, Wyer GmbH, Germany)&#xD;
      to maintain thermoregulation on the infant during delayed cord clamping.&#xD;
&#xD;
      If an infant is randomized to the DCC and Low Oxygen concentration (DCC LO group), the&#xD;
      following procedure will ensue:&#xD;
&#xD;
      During delayed cord clamping, the infant will be gently stimulated by drying the infant with&#xD;
      a sterile towel and provide CPAP by 30 seconds of life. During delayed cord clamping,&#xD;
      breathing assistance with CPAP of 5 cm H20 and a FiO2 0.3 will be provided.&#xD;
&#xD;
      If an infant is randomized to the DCC and High Oxygen concentration (DCC HI group), the&#xD;
      following procedure will ensue:&#xD;
&#xD;
      During delayed cord clamping, the infant will be gently stimulated by drying the infant with&#xD;
      a sterile towel and provide CPAP by 30 seconds of life. During delayed cord clamping,&#xD;
      breathing assistance with CPAP of 5 cm H20 and a FiO2 1.0 will be provided.&#xD;
&#xD;
      Patency of the airway in both groups will be assessed by a Colorimetric CO2 detector. Lack of&#xD;
      color change will indicate that the airway is not patent (obstructed), the pressure is not&#xD;
      sufficient to expand the lungs, there was excessive air leak, or there was no or inadequate&#xD;
      pulmonary blood flow. If there is no color change, the neonatal provider will reposition and&#xD;
      reattempt to open the airway, if no improvement they will initiate PPV (starting PIP of 20 cm&#xD;
      H20) by 60 seconds of life. Cord clamping will occur at 90 seconds or greater and the infant&#xD;
      will be transferred to a standard neonatal warmer and resuscitated per NRP guidelines.&#xD;
&#xD;
      Additionally, when available heart rate data will be collected using a non-invasive&#xD;
      dry-electrode monitor, (NeoBeat, Laerdal Medical, Stavanger, Norway) and applied over the&#xD;
      infant's chest or abdomen to provide continuous display of heart rate during 90 seconds of&#xD;
      DCC.&#xD;
&#xD;
      Pulse oximetry, ECG sensors and Near-Infrared Spectroscopy (NIRS) sensors will be applied&#xD;
      after cord clamping. The NIRS sensor will be placed on the infant's forehead. Cerebral StO2,&#xD;
      SpO2, blood pressure (once in the NICU) and Heart rate will be recorded every two seconds and&#xD;
      linked with other variables. These variables will continue to be recorded for the first 24&#xD;
      hours of life.&#xD;
&#xD;
      Blood sample will be collected at two different time points: Cord blood sample (T1: Cord&#xD;
      blood collected after the cord is cut) and at 2 hours of life or NICU admission (T2). This is&#xD;
      extra few drops of blood that is drawn from the baby for medical purposes (cord blood from&#xD;
      cord gases and admission blood work up).&#xD;
&#xD;
      Samples will be tested for oxidized and reduced glutathione which are the most reliable and&#xD;
      comprehensive biomarkers of oxidative stress.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 17, 2021</start_date>
  <completion_date type="Anticipated">June 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Once consent is obtained and the research staff is notified of a subject's impending birth, our research team member will open a randomization card and set the oxygen blender on the special bed to either an FiO2 of .30 or 1.0 and cover the blender. The research team member will not be involved in the clinical care for the infant and will blind the clinical care team from the randomized assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of administration of oxygen during delayed cord clamping and it's impact on the incidence of preterm infants (up to 28 +6 weeks) who achieve a peripheral oxygen saturation of 80 percent by 5 minutes of life</measure>
    <time_frame>by 5 minutes of life</time_frame>
    <description>To assess the feasibility and compare the incidence of preterm infants (up to 28+6 weeks GA) who achieve a peripheral oxygen saturation of 80 percent by 5 MOL given mask CPAP/PPV with an FiO2 of 1.0 during DCC for 90 seconds (HI Group) to infants given mask CPAP/PPV with an FiO2 of .30 during DCC for 90 seconds (LO Group).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All Grade IVH</measure>
    <time_frame>Through study completion at hospital discharge, up to 6 months corrected gestational age (CGA)</time_frame>
    <description>Any Intraventricular Hemorrhage (grades 1-4)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Grade III and IV intraventricular hemorrhage</measure>
    <time_frame>Through study completion at hospital discharge, up to 6 months corrected gestational age (CGA)</time_frame>
    <description>Intraventricular hemorrhages (grades 3-4) (bleeding in the brain parenchyma and/or ventricular dilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resuscitation interventions</measure>
    <time_frame>In the first 10 minutes of life</time_frame>
    <description>Resuscitation interventions including intubation, chest compressions, medications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in heart rate (BPM) in the first 10 minutes of life</measure>
    <time_frame>In the first 10 minutes of life</time_frame>
    <description>Changes in heart rate (BPM) in the first 10 minutes of life</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in Inspired fractional oxygen (FiO2)</measure>
    <time_frame>In the first 10 minutes of life</time_frame>
    <description>Changes in Inspired fractional oxygen (FiO2)</description>
  </other_outcome>
  <other_outcome>
    <measure>Duration of Hypoxia</measure>
    <time_frame>The first 10 minutes of life in the delivery room</time_frame>
    <description>Duration of Hypoxia (defined as oxygen saturation&lt;25th percentile of target ranges defined by Dawson et al.) in the first 10 minutes after birth</description>
  </other_outcome>
  <other_outcome>
    <measure>Duration of Hyperoxia</measure>
    <time_frame>The first 10 minutes of life in the delivery room</time_frame>
    <description>Duration of Hyperoxia (defined as oxygen saturation&gt;95%) in the first 10 minutes after birth</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Mean airway pressure, MAP (cm H20)</measure>
    <time_frame>In the first 10 minutes of life</time_frame>
    <description>Changes in Mean airway pressure, MAP (cm H20)</description>
  </other_outcome>
  <other_outcome>
    <measure>Duration of Positive Pressure Ventilation</measure>
    <time_frame>The first 10 minutes of life in the delivery room</time_frame>
    <description>Duration of positive pressure ventilation</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood pressures in the first 24 hours of life</measure>
    <time_frame>In the first 24 hours of life</time_frame>
    <description>Blood pressures every hour in the first 24 hours of life</description>
  </other_outcome>
  <other_outcome>
    <measure>Cerebral tissue oxygenation in the first 24 hours of life</measure>
    <time_frame>In the first 24 hours of life</time_frame>
    <description>Cerebral tissue oxygenation in the first 24 hours of life</description>
  </other_outcome>
  <other_outcome>
    <measure>Average oxygen saturation in the first 5 minutes after birth</measure>
    <time_frame>by 5 minutes of life</time_frame>
    <description>Oxygen saturation in the first 5 minutes after birth</description>
  </other_outcome>
  <other_outcome>
    <measure>Average Heart rate in the first 5 minutes after birth</measure>
    <time_frame>by 5 minutes of life</time_frame>
    <description>Heart rate in the first 5 minutes after birth</description>
  </other_outcome>
  <other_outcome>
    <measure>Intubation in the Delivery room or Neonatal Intensive Care Unit (NICU)</measure>
    <time_frame>Birth through study completion at discharge, up to 6 months of corrected gestational age</time_frame>
    <description>Intubation in the Delivery room or Neonatal Intensive Care Unit (NICU)</description>
  </other_outcome>
  <other_outcome>
    <measure>Lowest and Highest Hemoglobin and/or Hematocrit</measure>
    <time_frame>First 24 hours of life</time_frame>
    <description>Hemoglobin and/or Hematocrit levels (before transfusion)</description>
  </other_outcome>
  <other_outcome>
    <measure>Mean arterial blood pressure</measure>
    <time_frame>First 24 hours of life</time_frame>
    <description>Mean arterial blood pressure (collected hourly)</description>
  </other_outcome>
  <other_outcome>
    <measure>Medication for Low Blood Pressure</measure>
    <time_frame>First 24 hours of life</time_frame>
    <description>Medication for Low Blood Pressure (e.g. hydrocortisone or pressors)</description>
  </other_outcome>
  <other_outcome>
    <measure>CRIB-II (Clinical Risk Index for Babies)</measure>
    <time_frame>First 12 hours of life</time_frame>
    <description>CRIB-II (Clinical Risk Index for Babies)</description>
  </other_outcome>
  <other_outcome>
    <measure>Duration of mechanical ventilation and/or CPAP</measure>
    <time_frame>Birth through study completion at discharge, up to 6 months of corrected gestational age</time_frame>
    <description>Number of days on mechanical ventilation and/or CPAP</description>
  </other_outcome>
  <other_outcome>
    <measure>Surfactant administration</measure>
    <time_frame>Immediately after intervention through study completion at hospital discharge, up to 6 months of corrected gestational age</time_frame>
    <description>Surfactant administration</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of RBC Transfusions since birth</measure>
    <time_frame>First 10 days after birth</time_frame>
    <description>Number of RBC Transfusions since birth</description>
  </other_outcome>
  <other_outcome>
    <measure>Patent Ductus Arteriosus requiring pharmacological or surgical treatment</measure>
    <time_frame>Through study completion at discharge, up to 6 months of corrected gestational age</time_frame>
    <description>Patent Ductus Arteriosus requiring pharmacological or surgical treatment</description>
  </other_outcome>
  <other_outcome>
    <measure>Spontaneous Intestinal Perforation (SIP) requiring surgery or peritoneal drain</measure>
    <time_frame>Through study completion at discharge, up to 6 months of corrected gestational age</time_frame>
    <description>Spontaneous Intestinal Perforation (SIP) requiring surgery or peritoneal drain</description>
  </other_outcome>
  <other_outcome>
    <measure>Necrotizing Enterocolitis (Modified Bell's stage 2-3)</measure>
    <time_frame>Through study completion at discharge, up to 6 months of corrected gestational age</time_frame>
    <description>Necrotizing Enterocolitis (Modified Bell's stage 2-3)</description>
  </other_outcome>
  <other_outcome>
    <measure>Bronchopulmonary Dysplasia (mode of respiratory support administered at 36 weeks postmenstrual age; as defined and categorized in; Jensen, Dysart, Gantz, et al: Defining Bronchopulmonary Dysplasia) http://www.ncbi.nlm.nih.gov/pmc/articles/pmc6775872/</measure>
    <time_frame>Hospital course until 36 weeks PMA</time_frame>
    <description>Bronchopulmonary Dysplasia (mode of respiratory support administered at 36 weeks postmenstrual age; as defined and categorized in; Jensen, Dysart, Gantz, et al: Defining Bronchopulmonary Dysplasia) http://www.ncbi.nlm.nih.gov/pmc/articles/pmc6775872/</description>
  </other_outcome>
  <other_outcome>
    <measure>Severe ROP (stage 3 or treated with laser or bevacizumab)</measure>
    <time_frame>After the intervention through study completion at hospital discharge, up to 6 months of corrected gestational age</time_frame>
    <description>Severe ROP (stage 3 or treated with laser or bevacizumab)</description>
  </other_outcome>
  <other_outcome>
    <measure>Combined outcome of severe IVH and/or death</measure>
    <time_frame>Through study completion at death or discharge, up to 6 months of corrected gestational age</time_frame>
    <description>Combined outcome of severe IVH and/or death</description>
  </other_outcome>
  <other_outcome>
    <measure>Death</measure>
    <time_frame>Through study completion at death or discharge, up to 6 months of corrected gestational age</time_frame>
    <description>Death</description>
  </other_outcome>
  <other_outcome>
    <measure>SVC Flow</measure>
    <time_frame>6 hours of life</time_frame>
    <description>Superior Vena Cava flow by echocardiography</description>
  </other_outcome>
  <other_outcome>
    <measure>RVO</measure>
    <time_frame>6 hours of life</time_frame>
    <description>Right Ventricular output by echocardiography</description>
  </other_outcome>
  <other_outcome>
    <measure>Left Ventricular Output</measure>
    <time_frame>6 hours of life</time_frame>
    <description>Left Ventricular output by echocardiography</description>
  </other_outcome>
  <other_outcome>
    <measure>Cognitive Composite Score</measure>
    <time_frame>24 months corrected age</time_frame>
    <description>Composite Score (cognitive 45-155; higher scores are better) as assessed by the Bayley Scales of Infant and Toddler Development Fourth Edition</description>
  </other_outcome>
  <other_outcome>
    <measure>Language Composite Score</measure>
    <time_frame>24 months corrected age</time_frame>
    <description>Composite Score (language 45-155; higher scores are better) as assessed by the Bayley Scales of Infant and Toddler Development Fourth Edition</description>
  </other_outcome>
  <other_outcome>
    <measure>Motor Composite Score</measure>
    <time_frame>24 months corrected age</time_frame>
    <description>Composite Score (motor 45-155; higher scores are better) as assessed by the Bayley Scales of Infant and Toddler Development Fourth Edition</description>
  </other_outcome>
  <other_outcome>
    <measure>Cerebral Palsy</measure>
    <time_frame>24 months corrected age</time_frame>
    <description>As assessed by Gross Motor Function Classification System (GMFCS) Levels 1-5</description>
  </other_outcome>
  <other_outcome>
    <measure>Neurodevelopmental Outcome at 2 Years of Age</measure>
    <time_frame>22-26 months corrected age</time_frame>
    <description>Overall and Domain Scores- Ages and Stages, 3rd ed. Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Pulsatility Index</measure>
    <time_frame>6 hours of life</time_frame>
    <description>Pulsatility index calculated from Doppler of the Middle Cerebral Artery</description>
  </other_outcome>
  <other_outcome>
    <measure>Resistive Index</measure>
    <time_frame>6 hours of life</time_frame>
    <description>Resistive index calculated from Doppler of the Middle Cerebral Artery</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in cerebral oxygenation saturation, StO2 (%)</measure>
    <time_frame>In the first 10 minutes of life</time_frame>
    <description>Changes in cerebral oxygenation saturation, StO2 (%)</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in SpO2 (%) in the first 10 minutes of life</measure>
    <time_frame>In the first 10 minutes of life</time_frame>
    <description>Changes in SpO2 (%) in the first 10 minutes of life</description>
  </other_outcome>
  <other_outcome>
    <measure>Inhaled Nitric Oxide</measure>
    <time_frame>Immediately after intervention through study completion at hospital discharge, up to 6 months of corrected gestational age</time_frame>
    <description>Use of Inhaled Nitric Oxide for Respiratory failure or Pulmonary Hypertension</description>
  </other_outcome>
  <other_outcome>
    <measure>Glutathione (GSH/GSSG ratio)</measure>
    <time_frame>from birth up to NICU admission or in the first 2 hours of life</time_frame>
    <description>Assessment of oxidative biomarkers from birth up to 2 hours of life</description>
  </other_outcome>
  <other_outcome>
    <measure>Thermoregulation</measure>
    <time_frame>from 5 minutes of life up to NICU admission in the first 2 hours of life</time_frame>
    <description>Assessment of thermoregulation (axillary temperatures measured in degrees Celsius) during delayed cord clamping on extremely low gestational infants</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of Early Onset Sepsis</measure>
    <time_frame>From birth up to 72 hours of life</time_frame>
    <description>assessment of early onset sepsis with a positive blood or CSF culture at &lt;/= 72 HOL</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of Late Onset Sepsis</measure>
    <time_frame>From &gt; 72 hours of life through study completion at death or discharge, up to 6 months of corrected gestational age</time_frame>
    <description>assessment of late onset sepsis with a positive blood or CSF culture at &gt; 72 HOL</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>IVH- Intraventricular Hemorrhage</condition>
  <condition>Extreme Prematurity</condition>
  <condition>Hypoxia Neonatal</condition>
  <condition>Hyperoxia</condition>
  <condition>Respiratory Insufficiency</condition>
  <arm_group>
    <arm_group_label>DCC and Low Oxygen Concentration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During 90 seconds of delayed cord clamping, the infant will receive gentle stimulation and start CPAP by 30 seconds of life at an FiO2 .30, with CPAP of 5 cmH20. If the infant is apneic or there is no Pedicap color change the team will begin positive pressure ventilation (starting PIP of 20 cmH20) by 60 seconds of life. The infant will remain on this support up until the umbilical cord is clamped at 90 seconds or greater. Once the cord is clamped the infant resuscitation will continue according to unit protocol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DCC and High Oxygen Concentration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During 90 seconds of delayed cord clamping, the infant will receive gentle stimulation and start CPAP by 30 seconds of life at an FiO2 1.0, with CPAP of 5 cmH20. If the infant is apneic or there is no Pedicap color change the team will begin positive pressure ventilation (starting PIP of 20 cmH20) by 60 seconds of life. The infant will remain on this support up until the umbilical cord is clamped at 90 seconds or greater. Once the cord is clamped the infant resuscitation will continue according to unit protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Delayed Cord Clamping with Low Oxygen concentration</intervention_name>
    <description>During delayed umbilical cord clamping of 90 seconds, breathing assistance with CPAP/PPV and low oxygen concentration (FiO2 0.30) will be provided.</description>
    <arm_group_label>DCC and Low Oxygen Concentration</arm_group_label>
    <other_name>DCC with Low Oxygen concentration</other_name>
    <other_name>DCC LO group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Delayed Cord Clamping with High Oxygen concentration</intervention_name>
    <description>During delayed umbilical cord clamping of 90 seconds, breathing assistance with CPAP/PPV and high oxygen concentration (FiO2 1.0) will be provided.</description>
    <arm_group_label>DCC and High Oxygen Concentration</arm_group_label>
    <other_name>DCC with High Oxygen concentration</other_name>
    <other_name>DCC HI group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  up to 28+6 weeks Gestational age&#xD;
&#xD;
          -  Single and Multiple pregnancy&#xD;
&#xD;
          -  All modes of delivery (vaginally or caesarean section)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parents decline consent&#xD;
&#xD;
          -  Congenital anomalies of the newborn&#xD;
&#xD;
          -  Bleeding Accreta&#xD;
&#xD;
          -  Monochorionic multiples with evidence of TTTS&#xD;
&#xD;
          -  Fetal or maternal risk (i.e. compromise)&#xD;
&#xD;
          -  Preterm Premature Rupture of Membranes prior to 20 weeks gestation&#xD;
&#xD;
          -  Parents request no resuscitation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Weeks</minimum_age>
    <maximum_age>28 Weeks</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>
  <overall_contact>
    <last_name>Anup Katheria, MD</last_name>
    <phone>858-939-4170</phone>
    <email>anup.katheria@sharp.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Felix Ines, RCP-RRT</last_name>
    <phone>858-939-4136</phone>
    <email>felix.ines@sharp.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of California Davis</name>
      <address>
        <city>Davis</city>
        <state>California</state>
        <zip>95618</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Payam Vali, MD</last_name>
      <phone>916-734-8672</phone>
      <email>pvali@ucdavis.edu</email>
    </contact>
  </location>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Anup C Katheria, MD</last_name>
      <phone>858-939-4198</phone>
      <email>anup.katheria@sharp.com</email>
    </contact>
    <contact_backup>
      <last_name>Felix Ines, RCP-RRT</last_name>
      <phone>858-939-4136</phone>
      <email>felix.ines@sharp.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Mercer JS, McGrath MM, Hensman A, Silver H, Oh W. Immediate and delayed cord clamping in infants born between 24 and 32 weeks: a pilot randomized controlled trial. J Perinatol. 2003 Sep;23(6):466-72. doi: 10.1038/sj.jp.7210970.</citation>
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  </reference>
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  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>July 31, 2023</last_update_submitted>
  <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 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 of Neonatal Research Institute</investigator_title>
  </responsible_party>
  <keyword>Delayed Cord Clamping</keyword>
  <keyword>IVH- Intraventricular Hemorrhage</keyword>
  <keyword>Hyperoxia in Neonates</keyword>
  <keyword>Hypoxia Neonatal</keyword>
  <keyword>Continuous Positive Airway Pressure (CPAP)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
    <mesh_term>Hyperoxia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be made available per NICHD requirements (National Institute of Child Health and Human Development)</ipd_description>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>2 years after primary publication</ipd_time_frame>
    <ipd_access_criteria>An archived dataset with documentation will be made available for additional users by outside investigators, in collaboration with the study investigators. We will work with NICHD program staff to develop a broad data sharing plan over time.</ipd_access_criteria>
  </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/NCT04413097
org study id: DOXIE
nct id: NCT04413097
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is being conducted to compare the incidence of preterm infants (up to 28+6 weeks
      GA) who achieve a peripheral oxygen saturation of 80 percent by 5 minutes of life (MOL) given
      mask CPAP/PPV with an FiO2 of 1.0 during DCC for 90 seconds (HI Group) to infants given mask
      CPAP/PPV with an FiO2 of .30 during DCC for 90 seconds (LO Group).
Prenatal consent will be obtained on infant's with estimated gestational age up to 28+6
      weeks. Shortly before delivery, infant's will be randomly assigned to receive either Low
      oxygen concentration (FiO2 .30) OR High oxygen concentration (FiO2 1.0) during 90 seconds of
      delayed cord clamping.

      Randomization and intervention will remain blinded to the clinical care team during the
      entire study period. The research team member will open a randomization card when notified of
      a subject's impending birth, review the protocol with the obstetric provider performing the
      procedure, set-up the sterile stabilization bed, and note the time it takes from delivery
      until the clamping and cutting of the umbilical cord in both groups.

      The research team member will set the oxygen blender as indicated by the randomization card
      and cover the blender to blind the FiO2 setting. The research team member will not be
      involved in the clinical care of the infant. The oxygen blender will be concealed from the
      clinical care team to ensure resuscitation maneuvers will not be biased.

      Data will be submitted to the statistician, who will remain blinded to the intervention for
      the duration of the study.

      At delivery, the infant will be placed on a platform that allows the infant to be close to
      the mother and the umbilical cord to remain intact for DCC. These beds are equipped with an
      oxygen blender, humidifier, t-piece resuscitator with mask, necessary to provide CPAP/PPV. At
      some centers the bed will be equipped with a radian warmer (Ceramotherm, Wyer GmbH, Germany)
      to maintain thermoregulation on the infant during delayed cord clamping.

      If an infant is randomized to the DCC and Low Oxygen concentration (DCC LO group), the
      following procedure will ensue:

      During delayed cord clamping, the infant will be gently stimulated by drying the infant with
      a sterile towel and provide CPAP by 30 seconds of life. During delayed cord clamping,
      breathing assistance with CPAP of 5 cm H20 and a FiO2 0.3 will be provided.

      If an infant is randomized to the DCC and High Oxygen concentration (DCC HI group), the
      following procedure will ensue:

      During delayed cord clamping, the infant will be gently stimulated by drying the infant with
      a sterile towel and provide CPAP by 30 seconds of life. During delayed cord clamping,
      breathing assistance with CPAP of 5 cm H20 and a FiO2 1.0 will be provided.

      Patency of the airway in both groups will be assessed by a Colorimetric CO2 detector. Lack of
      color change will indicate that the airway is not patent (obstructed), the pressure is not
      sufficient to expand the lungs, there was excessive air leak, or there was no or inadequate
      pulmonary blood flow. If there is no color change, the neonatal provider will reposition and
      reattempt to open the airway, if no improvement they will initiate PPV (starting PIP of 20 cm
      H20) by 60 seconds of life. Cord clamping will occur at 90 seconds or greater and the infant
      will be transferred to a standard neonatal warmer and resuscitated per NRP guidelines.

      Additionally, when available heart rate data will be collected using a non-invasive
      dry-electrode monitor, (NeoBeat, Laerdal Medical, Stavanger, Norway) and applied over the
      infant's chest or abdomen to provide continuous display of heart rate during 90 seconds of
      DCC.

      Pulse oximetry, ECG sensors and Near-Infrared Spectroscopy (NIRS) sensors will be applied
      after cord clamping. The NIRS sensor will be placed on the infant's forehead. Cerebral StO2,
      SpO2, blood pressure (once in the NICU) and Heart rate will be recorded every two seconds and
      linked with other variables. These variables will continue to be recorded for the first 24
      hours of life.

      Blood sample will be collected at two different time points: Cord blood sample (T1: Cord
      blood collected after the cord is cut) and at 2 hours of life or NICU admission (T2). This is
      extra few drops of blood that is drawn from the baby for medical purposes (cord blood from
      cord gases and admission blood work up).

      Samples will be tested for oxidized and reduced glutathione which are the most reliable and
      comprehensive biomarkers of oxidative stress.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Once consent is obtained and the research staff is notified of a subject's impending birth, our research team member will open a randomization card and set the oxygen blender on the special bed to either an FiO2 of .30 or 1.0 and cover the blender. The research team member will not be involved in the clinical care for the infant and will blind the clinical care team from the randomized assignment.
measure: Feasibility of administration of oxygen during delayed cord clamping and it's impact on the incidence of preterm infants (up to 28 +6 weeks) who achieve a peripheral oxygen saturation of 80 percent by 5 minutes of life
time frame: by 5 minutes of life
description: To assess the feasibility and compare the incidence of preterm infants (up to 28+6 weeks GA) who achieve a peripheral oxygen saturation of 80 percent by 5 MOL given mask CPAP/PPV with an FiO2 of 1.0 during DCC for 90 seconds (HI Group) to infants given mask CPAP/PPV with an FiO2 of .30 during DCC for 90 seconds (LO Group).
measure: All Grade IVH
time frame: Through study completion at hospital discharge, up to 6 months corrected gestational age (CGA)
description: Any Intraventricular Hemorrhage (grades 1-4)
measure: Frequency of Grade III and IV intraventricular hemorrhage
time frame: Through study completion at hospital discharge, up to 6 months corrected gestational age (CGA)
description: Intraventricular hemorrhages (grades 3-4) (bleeding in the brain parenchyma and/or ventricular dilation
measure: Resuscitation interventions
time frame: In the first 10 minutes of life
description: Resuscitation interventions including intubation, chest compressions, medications
measure: Changes in heart rate (BPM) in the first 10 minutes of life
time frame: In the first 10 minutes of life
description: Changes in heart rate (BPM) in the first 10 minutes of life
measure: Changes in Inspired fractional oxygen (FiO2)
time frame: In the first 10 minutes of life
description: Changes in Inspired fractional oxygen (FiO2)
measure: Duration of Hypoxia
time frame: The first 10 minutes of life in the delivery room
description: Duration of Hypoxia (defined as oxygen saturation<25th percentile of target ranges defined by Dawson et al.) in the first 10 minutes after birth
measure: Duration of Hyperoxia
time frame: The first 10 minutes of life in the delivery room
description: Duration of Hyperoxia (defined as oxygen saturation>95%) in the first 10 minutes after birth
measure: Changes in Mean airway pressure, MAP (cm H20)
time frame: In the first 10 minutes of life
description: Changes in Mean airway pressure, MAP (cm H20)
measure: Duration of Positive Pressure Ventilation
time frame: The first 10 minutes of life in the delivery room
description: Duration of positive pressure ventilation
measure: Blood pressures in the first 24 hours of life
time frame: In the first 24 hours of life
description: Blood pressures every hour in the first 24 hours of life
measure: Cerebral tissue oxygenation in the first 24 hours of life
time frame: In the first 24 hours of life
description: Cerebral tissue oxygenation in the first 24 hours of life
measure: Average oxygen saturation in the first 5 minutes after birth
time frame: by 5 minutes of life
description: Oxygen saturation in the first 5 minutes after birth
measure: Average Heart rate in the first 5 minutes after birth
time frame: by 5 minutes of life
description: Heart rate in the first 5 minutes after birth
measure: Intubation in the Delivery room or Neonatal Intensive Care Unit (NICU)
time frame: Birth through study completion at discharge, up to 6 months of corrected gestational age
description: Intubation in the Delivery room or Neonatal Intensive Care Unit (NICU)
measure: Lowest and Highest Hemoglobin and/or Hematocrit
time frame: First 24 hours of life
description: Hemoglobin and/or Hematocrit levels (before transfusion)
measure: Mean arterial blood pressure
time frame: First 24 hours of life
description: Mean arterial blood pressure (collected hourly)
measure: Medication for Low Blood Pressure
time frame: First 24 hours of life
description: Medication for Low Blood Pressure (e.g. hydrocortisone or pressors)
measure: CRIB-II (Clinical Risk Index for Babies)
time frame: First 12 hours of life
description: CRIB-II (Clinical Risk Index for Babies)
measure: Duration of mechanical ventilation and/or CPAP
time frame: Birth through study completion at discharge, up to 6 months of corrected gestational age
description: Number of days on mechanical ventilation and/or CPAP
measure: Surfactant administration
time frame: Immediately after intervention through study completion at hospital discharge, up to 6 months of corrected gestational age
description: Surfactant administration
measure: Number of RBC Transfusions since birth
time frame: First 10 days after birth
description: Number of RBC Transfusions since birth
measure: Patent Ductus Arteriosus requiring pharmacological or surgical treatment
time frame: Through study completion at discharge, up to 6 months of corrected gestational age
description: Patent Ductus Arteriosus requiring pharmacological or surgical treatment
measure: Spontaneous Intestinal Perforation (SIP) requiring surgery or peritoneal drain
time frame: Through study completion at discharge, up to 6 months of corrected gestational age
description: Spontaneous Intestinal Perforation (SIP) requiring surgery or peritoneal drain
measure: Necrotizing Enterocolitis (Modified Bell's stage 2-3)
time frame: Through study completion at discharge, up to 6 months of corrected gestational age
description: Necrotizing Enterocolitis (Modified Bell's stage 2-3)
measure: Bronchopulmonary Dysplasia (mode of respiratory support administered at 36 weeks postmenstrual age; as defined and categorized in; Jensen, Dysart, Gantz, et al: Defining Bronchopulmonary Dysplasia) http://www.ncbi.nlm.nih.gov/pmc/articles/pmc6775872/
time frame: Hospital course until 36 weeks PMA
description: Bronchopulmonary Dysplasia (mode of respiratory support administered at 36 weeks postmenstrual age; as defined and categorized in; Jensen, Dysart, Gantz, et al: Defining Bronchopulmonary Dysplasia) http://www.ncbi.nlm.nih.gov/pmc/articles/pmc6775872/
measure: Severe ROP (stage 3 or treated with laser or bevacizumab)
time frame: After the intervention through study completion at hospital discharge, up to 6 months of corrected gestational age
description: Severe ROP (stage 3 or treated with laser or bevacizumab)
measure: Combined outcome of severe IVH and/or death
time frame: Through study completion at death or discharge, up to 6 months of corrected gestational age
description: Combined outcome of severe IVH and/or death
measure: Death
time frame: Through study completion at death or discharge, up to 6 months of corrected gestational age
description: Death
measure: SVC Flow
time frame: 6 hours of life
description: Superior Vena Cava flow by echocardiography
measure: RVO
time frame: 6 hours of life
description: Right Ventricular output by echocardiography
measure: Left Ventricular Output
time frame: 6 hours of life
description: Left Ventricular output by echocardiography
measure: Cognitive Composite Score
time frame: 24 months corrected age
description: Composite Score (cognitive 45-155; higher scores are better) as assessed by the Bayley Scales of Infant and Toddler Development Fourth Edition
measure: Language Composite Score
time frame: 24 months corrected age
description: Composite Score (language 45-155; higher scores are better) as assessed by the Bayley Scales of Infant and Toddler Development Fourth Edition
measure: Motor Composite Score
time frame: 24 months corrected age
description: Composite Score (motor 45-155; higher scores are better) as assessed by the Bayley Scales of Infant and Toddler Development Fourth Edition
measure: Cerebral Palsy
time frame: 24 months corrected age
description: As assessed by Gross Motor Function Classification System (GMFCS) Levels 1-5
measure: Neurodevelopmental Outcome at 2 Years of Age
time frame: 22-26 months corrected age
description: Overall and Domain Scores- Ages and Stages, 3rd ed. Questionnaire
measure: Pulsatility Index
time frame: 6 hours of life
description: Pulsatility index calculated from Doppler of the Middle Cerebral Artery
measure: Resistive Index
time frame: 6 hours of life
description: Resistive index calculated from Doppler of the Middle Cerebral Artery
measure: Changes in cerebral oxygenation saturation, StO2 (%)
time frame: In the first 10 minutes of life
description: Changes in cerebral oxygenation saturation, StO2 (%)
measure: Changes in SpO2 (%) in the first 10 minutes of life
time frame: In the first 10 minutes of life
description: Changes in SpO2 (%) in the first 10 minutes of life
measure: Inhaled Nitric Oxide
time frame: Immediately after intervention through study completion at hospital discharge, up to 6 months of corrected gestational age
description: Use of Inhaled Nitric Oxide for Respiratory failure or Pulmonary Hypertension
measure: Glutathione (GSH/GSSG ratio)
time frame: from birth up to NICU admission or in the first 2 hours of life
description: Assessment of oxidative biomarkers from birth up to 2 hours of life
measure: Thermoregulation
time frame: from 5 minutes of life up to NICU admission in the first 2 hours of life
description: Assessment of thermoregulation (axillary temperatures measured in degrees Celsius) during delayed cord clamping on extremely low gestational infants
measure: Rate of Early Onset Sepsis
time frame: From birth up to 72 hours of life
description: assessment of early onset sepsis with a positive blood or CSF culture at </= 72 HOL
measure: Rate of Late Onset Sepsis
time frame: From > 72 hours of life through study completion at death or discharge, up to 6 months of corrected gestational age
description: assessment of late onset sepsis with a positive blood or CSF culture at > 72 HOL
arm group label: DCC and Low Oxygen Concentration
arm group type: Active Comparator
description: During 90 seconds of delayed cord clamping, the infant will receive gentle stimulation and start CPAP by 30 seconds of life at an FiO2 .30, with CPAP of 5 cmH20. If the infant is apneic or there is no Pedicap color change the team will begin positive pressure ventilation (starting PIP of 20 cmH20) by 60 seconds of life. The infant will remain on this support up until the umbilical cord is clamped at 90 seconds or greater. Once the cord is clamped the infant resuscitation will continue according to unit protocol.
arm group label: DCC and High Oxygen Concentration
arm group type: Experimental
description: During 90 seconds of delayed cord clamping, the infant will receive gentle stimulation and start CPAP by 30 seconds of life at an FiO2 1.0, with CPAP of 5 cmH20. If the infant is apneic or there is no Pedicap color change the team will begin positive pressure ventilation (starting PIP of 20 cmH20) by 60 seconds of life. The infant will remain on this support up until the umbilical cord is clamped at 90 seconds or greater. Once the cord is clamped the infant resuscitation will continue according to unit protocol.
intervention type: Procedure
intervention name: Delayed Cord Clamping with Low Oxygen concentration
description: During delayed umbilical cord clamping of 90 seconds, breathing assistance with CPAP/PPV and low oxygen concentration (FiO2 0.30) will be provided.
arm group label: DCC and Low Oxygen Concentration
other name: DCC with Low Oxygen concentration
other name: DCC LO group
intervention type: Procedure
intervention name: Delayed Cord Clamping with High Oxygen concentration
description: During delayed umbilical cord clamping of 90 seconds, breathing assistance with CPAP/PPV and high oxygen concentration (FiO2 1.0) will be provided.
arm group label: DCC and High Oxygen Concentration
other name: DCC with High Oxygen concentration
other name: DCC HI group
criteria: 
gender: All
minimum age: 22 Weeks
maximum age: 28 Weeks
healthy volunteers: No
last name: Anup Katheria, MD
role: Principal Investigator
affiliation: Sharp HealthCare
last name: Anup Katheria, MD
phone: 858-939-4170
email: anup.katheria@sharp.com
last name: Felix Ines, RCP-RRT
phone: 858-939-4136
email: felix.ines@sharp.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
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responsible party type: Principal Investigator
investigator affiliation: Sharp HealthCare
investigator full name: Anup Katheria, M.D.
investigator title: Director of Neonatal Research Institute
mesh term: Respiratory Insufficiency
mesh term: Hemorrhage
mesh term: Hypoxia
mesh term: Hyperoxia
sharing ipd: Yes
ipd description: Data will be made available per NICHD requirements (National Institute of Child Health and Human Development)
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: 2 years after primary publication
ipd access criteria: An archived dataset with documentation will be made available for additional users by outside investigators, in collaboration with the study investigators. We will work with NICHD program staff to develop a broad data sharing plan over time.