<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/NCT03231735</url>
  </required_header>
  <id_info>
    <org_study_id>F160701002</org_study_id>
    <nct_id>NCT03231735</nct_id>
  </id_info>
  <brief_title>Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome</brief_title>
  <acronym>MIDAS</acronym>
  <official_title>A Randomized Controlled Trial of Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of South Alabama</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</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>
      The purpose of this study is to determine, in preterm infants less than 37 weeks gestation&#xD;
      with respiratory distress who are ventilated in the first 48 hours after birth, if mid&#xD;
      frequency ventilation strategy using ventilator rate of ≥ 60 to ≤ 150 per minute compared&#xD;
      with standard frequency ventilation strategy using ventilator rates of ≥ 20 to &lt; 60 per&#xD;
      minute will increase the number of alive ventilator-free days after randomization and reduce&#xD;
      the risk of ventilator induced lung injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In preterm infants with respiratory distress syndrome (RDS) who are ventilated in the first&#xD;
      48 hours after birth, mid frequency ventilation (MFV) strategy, compared with standard&#xD;
      frequency ventilation (SFV) strategy, in the first week after birth, will increase the number&#xD;
      of days alive and ventilator-free in the 28 days after birth.&#xD;
&#xD;
      This will be a randomized controlled trial with a 1:1 parallel allocation of infants to MFV&#xD;
      or SFV using stratified permuted block design. Randomization will be stratified by&#xD;
      gestational age (≥ 23 weeks to ˂ 26 weeks, ≥ 26 weeks to ≤ 28+6/7 (less than 29 weeks), and&#xD;
      29+0/7 to 36+6/7). Randomization of twins and higher orders (when eligible) will be to the&#xD;
      same group.&#xD;
&#xD;
      Inborn and outborn infants who are receiving assisted ventilation for RDS in the first 48&#xD;
      hours after birth will be included in this study. Infants with any of the following: a major&#xD;
      malformation, a neuromuscular condition that affects respiration, terminal illness or&#xD;
      decision to withhold or limit support will not be eligible.&#xD;
&#xD;
      Infants will be randomized to MFV versus SFV. MFV delivered at rates &gt; 60 per minute and ≤&#xD;
      150 per minute, with patient triggered ventilation and pressure support.&#xD;
&#xD;
      SFV delivered at rates &lt; 60 per minute and ≥ 20 per minute, with patient triggered&#xD;
      ventilation and pressure support.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 2, 2017</start_date>
  <completion_date type="Anticipated">October 31, 2024</completion_date>
  <primary_completion_date type="Actual">November 21, 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</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>
    <intervention_model_description>This will be a randomized controlled trial with a 1:1 parallel allocation of infants to mid or standard frequency ventilation using stratified permuted block design.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Alive ventilator free days</measure>
    <time_frame>Days 1-28 after birth</time_frame>
    <description>The number of days alive and ventilator-free</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alive at day 28 after birth</measure>
    <time_frame>Day 28 after birth</time_frame>
    <description>Number of infants alive</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilator free</measure>
    <time_frame>Day 28 after birth</time_frame>
    <description>Number of infants ventilator free</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bronchopulmonary dysplasia</measure>
    <time_frame>Measured at 36 weeks' postmenstrual age</time_frame>
    <description>Bronchopulmonary dysplasia in preterm infants less than 32 weeks' gestation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bronchopulmonary dysplasia</measure>
    <time_frame>Measured at 36 weeks' postmenstrual age</time_frame>
    <description>Bronchopulmonary dysplasia in preterm infants less than 29 weeks' gestation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Air leak syndrome</measure>
    <time_frame>Day 1-28 after birth</time_frame>
    <description>Rate of pulmonary interstitial emphysema and/or pneumothorax</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary hemorrhage</measure>
    <time_frame>Day 1-28 after birth</time_frame>
    <description>Rate of pulmonary hemorrhage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe (grade 3-4) intracranial hemorrhage</measure>
    <time_frame>Day 1-30 after birth</time_frame>
    <description>Rate of severe (grade 3-4) intracranial hemorrhage in infants less than 29 weeks' gestation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alive and continuous positive airway pressure/ventilator free</measure>
    <time_frame>Day 1-28 after birth</time_frame>
    <description>Number of days alive and ontinuous positive airway pressure/ventilator free</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alive and oxygen free</measure>
    <time_frame>Day 1-28 after birth</time_frame>
    <description>Number of days alive and oxygen free</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postnatal steroids</measure>
    <time_frame>Before 36 weeks' postmenstrual age</time_frame>
    <description>Rate of post natal steroids for bronchopulmonary dysplasia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Necrotizing enterocolitis</measure>
    <time_frame>Days 1-120 after birth</time_frame>
    <description>Rate of proven necrotizing enterocolitis (NEC) in infants less than 29 weeks' gestation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurodevelopmental impairment</measure>
    <time_frame>18 to 24 months after birth</time_frame>
    <description>Rate of moderate to severe neurodevelopmental impairment in survivors &lt; 27 weeks' gestation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bronchopulmonary dysplasia or death</measure>
    <time_frame>Day 1-120 after birth</time_frame>
    <description>Rate of Bronchopulmonary dysplasia or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurodevelopmental impairment or death</measure>
    <time_frame>Day 1-120 after birth</time_frame>
    <description>Rate of Bronchopulmonary dysplasia or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bronchopulmonary dysplasia or death</measure>
    <time_frame>18 to 24 months after birth</time_frame>
    <description>Rate of moderate to severe neurodevelopmental impairment or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Necrotizing enterocolitis or death</measure>
    <time_frame>Day 1-120 after birth</time_frame>
    <description>Rate of proven necrotizing enterocolitis or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>Day 1-120 after birth</time_frame>
    <description>Death before hospital discharge</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Ventilator-Induced Lung Injury</condition>
  <condition>Respiratory Distress Syndrome</condition>
  <condition>Bronchopulmonary Dysplasia</condition>
  <condition>Preterm Infant</condition>
  <arm_group>
    <arm_group_label>Mid frequency ventilation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Mid frequency ventilation delivered at rates &gt; 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard frequency ventilation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard frequency ventilation delivered at rates &lt; 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mid frequency ventilation</intervention_name>
    <description>Mechanical ventilator used at rates &gt; 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support.</description>
    <arm_group_label>Mid frequency ventilation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard frequency ventilation</intervention_name>
    <description>Mechanical ventilator used at rates &lt; 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.</description>
    <arm_group_label>Standard frequency ventilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants ≥ 23+0/7 weeks and ≤ 36+6/7 who are intubated and mechanically ventilated for&#xD;
             respiratory distress syndrome (defined by use of surfactant) within 48 hours after&#xD;
             birth&#xD;
&#xD;
          -  Infants whose parents/legal guardians have provided consent for enrollment&#xD;
&#xD;
          -  Inborn or outborn infants transferred to this center before 48 hours after birth&#xD;
&#xD;
          -  Ventilator rate ≤ 80 per minute prior to enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a major malformation, a neuromuscular condition that affects respiration, or terminal&#xD;
             illness or decision to withhold or limit support.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>3 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Waldemar A Carlo, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Alabama</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>October 11, 2022</last_update_submitted>
  <last_update_submitted_qc>October 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Colm Travers</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Lung Injury</mesh_term>
    <mesh_term>Bronchopulmonary Dysplasia</mesh_term>
    <mesh_term>Ventilator-Induced Lung Injury</mesh_term>
    <mesh_term>Syndrome</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/NCT03231735
org study id: F160701002
nct id: NCT03231735
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine, in preterm infants less than 37 weeks gestation
      with respiratory distress who are ventilated in the first 48 hours after birth, if mid
      frequency ventilation strategy using ventilator rate of ≥ 60 to ≤ 150 per minute compared
      with standard frequency ventilation strategy using ventilator rates of ≥ 20 to < 60 per
      minute will increase the number of alive ventilator-free days after randomization and reduce
      the risk of ventilator induced lung injury.
In preterm infants with respiratory distress syndrome (RDS) who are ventilated in the first
      48 hours after birth, mid frequency ventilation (MFV) strategy, compared with standard
      frequency ventilation (SFV) strategy, in the first week after birth, will increase the number
      of days alive and ventilator-free in the 28 days after birth.

      This will be a randomized controlled trial with a 1:1 parallel allocation of infants to MFV
      or SFV using stratified permuted block design. Randomization will be stratified by
      gestational age (≥ 23 weeks to ˂ 26 weeks, ≥ 26 weeks to ≤ 28+6/7 (less than 29 weeks), and
      29+0/7 to 36+6/7). Randomization of twins and higher orders (when eligible) will be to the
      same group.

      Inborn and outborn infants who are receiving assisted ventilation for RDS in the first 48
      hours after birth will be included in this study. Infants with any of the following: a major
      malformation, a neuromuscular condition that affects respiration, terminal illness or
      decision to withhold or limit support will not be eligible.

      Infants will be randomized to MFV versus SFV. MFV delivered at rates > 60 per minute and ≤
      150 per minute, with patient triggered ventilation and pressure support.

      SFV delivered at rates < 60 per minute and ≥ 20 per minute, with patient triggered
      ventilation and pressure support.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This will be a randomized controlled trial with a 1:1 parallel allocation of infants to mid or standard frequency ventilation using stratified permuted block design.
primary purpose: Treatment
masking: None (Open Label)
measure: Alive ventilator free days
time frame: Days 1-28 after birth
description: The number of days alive and ventilator-free
measure: Alive at day 28 after birth
time frame: Day 28 after birth
description: Number of infants alive
measure: Ventilator free
time frame: Day 28 after birth
description: Number of infants ventilator free
measure: Bronchopulmonary dysplasia
time frame: Measured at 36 weeks' postmenstrual age
description: Bronchopulmonary dysplasia in preterm infants less than 32 weeks' gestation
measure: Bronchopulmonary dysplasia
time frame: Measured at 36 weeks' postmenstrual age
description: Bronchopulmonary dysplasia in preterm infants less than 29 weeks' gestation
measure: Air leak syndrome
time frame: Day 1-28 after birth
description: Rate of pulmonary interstitial emphysema and/or pneumothorax
measure: Pulmonary hemorrhage
time frame: Day 1-28 after birth
description: Rate of pulmonary hemorrhage
measure: Severe (grade 3-4) intracranial hemorrhage
time frame: Day 1-30 after birth
description: Rate of severe (grade 3-4) intracranial hemorrhage in infants less than 29 weeks' gestation
measure: Alive and continuous positive airway pressure/ventilator free
time frame: Day 1-28 after birth
description: Number of days alive and ontinuous positive airway pressure/ventilator free
measure: Alive and oxygen free
time frame: Day 1-28 after birth
description: Number of days alive and oxygen free
measure: Postnatal steroids
time frame: Before 36 weeks' postmenstrual age
description: Rate of post natal steroids for bronchopulmonary dysplasia
measure: Necrotizing enterocolitis
time frame: Days 1-120 after birth
description: Rate of proven necrotizing enterocolitis (NEC) in infants less than 29 weeks' gestation
measure: Neurodevelopmental impairment
time frame: 18 to 24 months after birth
description: Rate of moderate to severe neurodevelopmental impairment in survivors < 27 weeks' gestation
measure: Bronchopulmonary dysplasia or death
time frame: Day 1-120 after birth
description: Rate of Bronchopulmonary dysplasia or death
measure: Neurodevelopmental impairment or death
time frame: Day 1-120 after birth
description: Rate of Bronchopulmonary dysplasia or death
measure: Bronchopulmonary dysplasia or death
time frame: 18 to 24 months after birth
description: Rate of moderate to severe neurodevelopmental impairment or death
measure: Necrotizing enterocolitis or death
time frame: Day 1-120 after birth
description: Rate of proven necrotizing enterocolitis or death
measure: Death
time frame: Day 1-120 after birth
description: Death before hospital discharge
arm group label: Mid frequency ventilation
arm group type: Other
description: Mid frequency ventilation delivered at rates > 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support.
arm group label: Standard frequency ventilation
arm group type: Other
description: Standard frequency ventilation delivered at rates < 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.
intervention type: Device
intervention name: Mid frequency ventilation
description: Mechanical ventilator used at rates > 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support.
arm group label: Mid frequency ventilation
intervention type: Device
intervention name: Standard frequency ventilation
description: Mechanical ventilator used at rates < 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.
arm group label: Standard frequency ventilation
criteria: 
gender: All
minimum age: 1 Day
maximum age: 3 Days
healthy volunteers: No
last name: Waldemar A Carlo, MD
role: Study Director
affiliation: University of Alabama at Birmingham
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Colm Travers
investigator title: Principal Investigator
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Lung Injury
mesh term: Bronchopulmonary Dysplasia
mesh term: Ventilator-Induced Lung Injury
mesh term: Syndrome
sharing ipd: No