<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/NCT01697904</url>
  </required_header>
  <id_info>
    <org_study_id>STU 052011-044</org_study_id>
    <nct_id>NCT01697904</nct_id>
  </id_info>
  <brief_title>Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns</brief_title>
  <official_title>Randomized Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Preterm infants are born with immature lungs and often require help with breathing shortly&#xD;
      after birth. This traditionally involves administering 100% oxygen. Unfortunately, delivery&#xD;
      of high oxygen concentrations leads to the production of free radicals that can injure many&#xD;
      organ systems. Term and near-term newborns deprived of oxygen during or prior to birth&#xD;
      respond as well or better to resuscitation with room air (21% oxygen) compared to 100%&#xD;
      oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm&#xD;
      infants with lung disease.Purpose of the study is to investigate if preterm neonates where&#xD;
      resuscitation is initiated with 21% fiO2 and adjusted to meet transitional goal saturations&#xD;
      (Limited oxygen strategy or LOX) would have less oxidative stress as measured by the&#xD;
      oxidative balance ratio of biological antioxidant potential/total hydroperoxide compared to&#xD;
      infants where resuscitation is initiated with pure oxygen and titrated for targeted&#xD;
      saturations of 85-94% (Traditional oxygen strategy or TOX). Secondary outcomes of interest&#xD;
      included need for other delivery room resuscitation measures, respiratory support and&#xD;
      ventilation/oxygenation status upon neonatal intensive care unit (NICU) admission, survival&#xD;
      to hospital discharge, bronchopulmonary dysplasia and other short-term morbidities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2010</start_date>
  <completion_date type="Actual">January 2011</completion_date>
  <primary_completion_date type="Actual">January 2011</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in mean oxidative balance ratio at 1 hour of life</measure>
    <time_frame>Cord blood and at 1 hour of life</time_frame>
    <description>Total hydroperoxide(TH), Biological antioxidant potential (BAP)were measured at 1 hour of life in all preterm infants. Oxidative balance ratio was calculated from this formula. Oxidative balance ratio = BAP/TH.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total oxygen load used during active resuscitation</measure>
    <time_frame>First 10 minutes of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saturations achieved during first 10 minutes of life</measure>
    <time_frame>First 10 minutes of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Significant bradycardia ( HR&lt;60 beats per minute) after 90 seconds in either group during active resuscitation</measure>
    <time_frame>First 10 minutes of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time spent with saturation above 94% during active resuscitation</measure>
    <time_frame>First 10 minutes of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for respiratory support in the delivery room</measure>
    <time_frame>First 10 minutes of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bronchopulmonary dysplasia</measure>
    <time_frame>36 weeks postconceptional age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospitalization</measure>
    <time_frame>From date of randomization to date of discharge, expected average of 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinopathy of Prematurity</measure>
    <time_frame>40 weeks postconceptional age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal mortality</measure>
    <time_frame>28 days of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death before discharge</measure>
    <time_frame>From date of randomization to date of discharge, expected average of 8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Prematurity</condition>
  <condition>Oxidative Stress</condition>
  <arm_group>
    <arm_group_label>Low Oxygen Strategy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Resuscitation was initiated with room air (21% O2) for LOX infants. Supplemental oxygen was given if 1) the heart rate (HR) was less than 100 bpm after 30 seconds of effective ventilation, 2) the lower limits of goal saturations were not met. Targeted goal Pre-ductal saturations after birth were derived by approximation of the interquartile values for healthy term infants as reported by Kamlin et al and Dawson et al.FiO2 was increased or decreased by 10% in 30 second intervals as needed. If HR &lt; 60 bpm after 30 seconds of effective ventilation , FiO2 was increased to 100% until the heart rate was stabilized.&#xD;
Targeted Pre-ductal SpO2 After birth&#xD;
min 60%-65%&#xD;
min 65%-70%&#xD;
min 70%-75%&#xD;
min 75%-80%&#xD;
min 80%-85%&#xD;
10 min 85%-94%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional Oxygen strategy ( TOX)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Resuscitation for TOX infants was started with 100% O2 and adjusted every 30 seconds by 10% to meet the target oxygen saturation range of 85-94%</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Titration of oxygen during newborn resuscitation in delivery room</intervention_name>
    <arm_group_label>Low Oxygen Strategy</arm_group_label>
    <arm_group_label>Traditional Oxygen strategy ( TOX)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inborn&#xD;
&#xD;
          -  Gestation age 24 0/7 to 34 6/7&#xD;
&#xD;
          -  Need for active resuscitation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prenatally diagnosed cyanotic congenital heart disease&#xD;
&#xD;
          -  Non-viable newborns&#xD;
&#xD;
          -  Precipitous delivery and resuscitation team not present in the delivery room to&#xD;
             initiate resuscitation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vishal S Kapadia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Myra H Wyckoff, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parkland Memorial Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>October 1, 2012</last_update_submitted>
  <last_update_submitted_qc>October 1, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Vishal Kapadia</investigator_full_name>
    <investigator_title>Assistant Professor of Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</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/NCT01697904
org study id: STU 052011-044
nct id: NCT01697904
lead sponsor: 
has dmc: No
Preterm infants are born with immature lungs and often require help with breathing shortly
      after birth. This traditionally involves administering 100% oxygen. Unfortunately, delivery
      of high oxygen concentrations leads to the production of free radicals that can injure many
      organ systems. Term and near-term newborns deprived of oxygen during or prior to birth
      respond as well or better to resuscitation with room air (21% oxygen) compared to 100%
      oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm
      infants with lung disease.Purpose of the study is to investigate if preterm neonates where
      resuscitation is initiated with 21% fiO2 and adjusted to meet transitional goal saturations
      (Limited oxygen strategy or LOX) would have less oxidative stress as measured by the
      oxidative balance ratio of biological antioxidant potential/total hydroperoxide compared to
      infants where resuscitation is initiated with pure oxygen and titrated for targeted
      saturations of 85-94% (Traditional oxygen strategy or TOX). Secondary outcomes of interest
      included need for other delivery room resuscitation measures, respiratory support and
      ventilation/oxygenation status upon neonatal intensive care unit (NICU) admission, survival
      to hospital discharge, bronchopulmonary dysplasia and other short-term morbidities.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reduction in mean oxidative balance ratio at 1 hour of life
time frame: Cord blood and at 1 hour of life
description: Total hydroperoxide(TH), Biological antioxidant potential (BAP)were measured at 1 hour of life in all preterm infants. Oxidative balance ratio was calculated from this formula. Oxidative balance ratio = BAP/TH.
measure: Total oxygen load used during active resuscitation
time frame: First 10 minutes of life
measure: Saturations achieved during first 10 minutes of life
time frame: First 10 minutes of life
measure: Significant bradycardia ( HR<60 beats per minute) after 90 seconds in either group during active resuscitation
time frame: First 10 minutes of life
measure: Time spent with saturation above 94% during active resuscitation
time frame: First 10 minutes of life
measure: Need for respiratory support in the delivery room
time frame: First 10 minutes of life
measure: Bronchopulmonary dysplasia
time frame: 36 weeks postconceptional age
measure: Length of hospitalization
time frame: From date of randomization to date of discharge, expected average of 8 weeks
measure: Retinopathy of Prematurity
time frame: 40 weeks postconceptional age
measure: Neonatal mortality
time frame: 28 days of life
measure: Death before discharge
time frame: From date of randomization to date of discharge, expected average of 8 weeks
arm group label: Low Oxygen Strategy
arm group type: Experimental
description: Resuscitation was initiated with room air (21% O2) for LOX infants. Supplemental oxygen was given if 1) the heart rate (HR) was less than 100 bpm after 30 seconds of effective ventilation, 2) the lower limits of goal saturations were not met. Targeted goal Pre-ductal saturations after birth were derived by approximation of the interquartile values for healthy term infants as reported by Kamlin et al and Dawson et al.FiO2 was increased or decreased by 10% in 30 second intervals as needed. If HR < 60 bpm after 30 seconds of effective ventilation , FiO2 was increased to 100% until the heart rate was stabilized.
Targeted Pre-ductal SpO2 After birth
min 60%-65%
min 65%-70%
min 70%-75%
min 75%-80%
min 80%-85%
10 min 85%-94%
arm group label: Traditional Oxygen strategy ( TOX)
arm group type: Active Comparator
description: Resuscitation for TOX infants was started with 100% O2 and adjusted every 30 seconds by 10% to meet the target oxygen saturation range of 85-94%
intervention type: Procedure
intervention name: Titration of oxygen during newborn resuscitation in delivery room
arm group label: Low Oxygen Strategy
arm group label: Traditional Oxygen strategy ( TOX)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Vishal S Kapadia, MD
role: Principal Investigator
affiliation: UT Southwestern
last name: Myra H Wyckoff, MD
role: Principal Investigator
affiliation: UT Southwestern
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Vishal Kapadia
investigator title: Assistant Professor of Pediatrics
mesh term: Premature Birth