xml: <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/NCT05986032</url>
    </required_header>
    <id_info>
      <org_study_id>REACT</org_study_id>
      <nct_id>NCT05986032</nct_id>
    </id_info>
    <brief_title>Respiratory Oscillometry for the Prediction of Bronchopulmonary Dysplasia</brief_title>
    <acronym>REACT</acronym>
    <official_title>Relationship Between Respiratory System Reactance Assessed by Respiratory Oscillometry and Respiratory Outcomes in Very Preterm Infants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione IRCCS San Gerardo dei Tintori</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University Children's Hospital Basel</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Uppsala University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Medical University of Vienna</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Fondazione IRCCS San Gerardo dei Tintori</source>
    <brief_summary>
      <textblock>
        The goal of this observational study is to learn about the correlation between respiratory&#xD;
        system reactance, as assessed by respiratory oscillometry, and respiratory outcomes in&#xD;
        preterm infants born before 32 weeks of gestation. The main question it aims to answer is if&#xD;
        the reactance z-score at 7 postnatal days adds to relevant clinical factors in the prediction&#xD;
        of bronchopulmonary dysplasia. Participants will receive respiratory oscillometry&#xD;
        measurements at 7 ± 2 postnatal days.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 24, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 3, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure</measure>
      <time_frame>Xrs will be measured at 7 days of life</time_frame>
      <description>Xrs will be expressed in z-score using reference equation for very preterm infants</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure and ± 2 cmH2O</measure>
      <time_frame>Xrs will be measured at 7 days of life</time_frame>
      <description>Xrs will be expressed in cmH2O*S/L</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Respiratory support mode</measure>
      <time_frame>7 postnatal days</time_frame>
      <description>Respiratory support mode will be coded as 0 = no respiratory support, 1 = nasal high flow therapy, 2 = nasal CPAP or nasal IPPV, 3 = invasive mechanical ventilation</description>
    </other_outcome>
    <other_outcome>
      <measure>Fraction of inspired oxygen</measure>
      <time_frame>7 days of life</time_frame>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Bronchopulmonary Dysplasia</condition>
    <arm_group>
      <arm_group_label>no bronchopulmonary dysplasia</arm_group_label>
      <description>Group of patients who do not receive the diagnosis of bronchopulmonary dysplasia defined as the need for respiratory support at 36 weeks post-mentrual age</description>
    </arm_group>
    <arm_group>
      <arm_group_label>bronchopulmonary dysplasia</arm_group_label>
      <description>Group of patients developing bronchopulmonary dysplasia defined as the need for respiratory support at 36 weeks post-menstrual age.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Respiratory Oscillometry</intervention_name>
      <description>Measurement of respiratory system reactance by respiratory oscillometry</description>
      <arm_group_label>bronchopulmonary dysplasia</arm_group_label>
      <arm_group_label>no bronchopulmonary dysplasia</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Infants will be recruited from those admitted to tertiary-level neonatal intensive care&#xD;
          units.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  born before 32 weeks post-menstrual age&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  congenital abnormalities&#xD;
  &#xD;
            -  Inherited disorders of metabolism&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Days</minimum_age>
      <maximum_age>9 Days</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Camilla Rigotti, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fondazione IRCCS San Gerardo dei Tintori</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Camilla Rigotti, PhD</last_name>
      <phone>+39039233</phone>
      <phone_ext>9173</phone_ext>
      <email>dr.camilla.rigotti@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Emanuela Zannin, PhD</last_name>
      <phone>+393389323437</phone>
      <email>emanuela.zannin@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Medical University of Vienna</name>
        <address>
          <city>Vienna</city>
          <state>Wien</state>
          <zip>1090</zip>
          <country>Austria</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Fondazione IRCCS San Gerardo dei Tintori</name>
        <address>
          <city>Monza</city>
          <state>Monza E Brianza</state>
          <zip>20900</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico</name>
        <address>
          <city>Milano</city>
          <zip>20122</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Amsterdam UMC</name>
        <address>
          <city>Amsterdam</city>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Uppsala University Children's Hospital</name>
        <address>
          <city>Uppsala</city>
          <zip>S-751 85</zip>
          <country>Sweden</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Universitäts-Kinderspital beider Basel</name>
        <address>
          <city>Basel</city>
          <zip>4056</zip>
          <country>Switzerland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Austria</country>
      <country>Italy</country>
      <country>Netherlands</country>
      <country>Sweden</country>
      <country>Switzerland</country>
    </location_countries>
    <reference>
      <citation>Zannin E, Neumann RP, Dellaca R, Schulzke SM. Forced oscillation measurements in the first week of life and pulmonary outcome in very preterm infants on noninvasive respiratory support. Pediatr Res. 2019 Sep;86(3):382-388. doi: 10.1038/s41390-019-0432-6. Epub 2019 May 20.</citation>
      <PMID>31108499</PMID>
    </reference>
    <reference>
      <citation>Veneroni C, Wallstrom L, Sindelar R, Dellaca' RL. Oscillatory respiratory mechanics on the first day of life improves prediction of respiratory outcomes in extremely preterm newborns. Pediatr Res. 2019 Feb;85(3):312-317. doi: 10.1038/s41390-018-0133-6. Epub 2018 Aug 4.</citation>
      <PMID>30127523</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Respiratory oscillometry</keyword>
    <keyword>Respiratory system reactance</keyword>
    <keyword>Lung mechanics</keyword>
    <keyword>Infant lung function testing</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bronchopulmonary Dysplasia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05986032
  org study id: REACT
  nct id: NCT05986032
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  The goal of this observational study is to learn about the correlation between respiratory
        system reactance, as assessed by respiratory oscillometry, and respiratory outcomes in
        preterm infants born before 32 weeks of gestation. The main question it aims to answer is if
        the reactance z-score at 7 postnatal days adds to relevant clinical factors in the prediction
        of bronchopulmonary dysplasia. Participants will receive respiratory oscillometry
        measurements at 7 ± 2 postnatal days.
  observational model: Cohort
  time perspective: Retrospective
  measure: Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure
  time frame: Xrs will be measured at 7 days of life
  description: Xrs will be expressed in z-score using reference equation for very preterm infants
  measure: Respiratory system reactance (Xrs) at the clinical positive end-expiratory pressure and ± 2 cmH2O
  time frame: Xrs will be measured at 7 days of life
  description: Xrs will be expressed in cmH2O*S/L
  measure: Respiratory support mode
  time frame: 7 postnatal days
  description: Respiratory support mode will be coded as 0 = no respiratory support, 1 = nasal high flow therapy, 2 = nasal CPAP or nasal IPPV, 3 = invasive mechanical ventilation
  measure: Fraction of inspired oxygen
  time frame: 7 days of life
  arm group label: no bronchopulmonary dysplasia
  description: Group of patients who do not receive the diagnosis of bronchopulmonary dysplasia defined as the need for respiratory support at 36 weeks post-mentrual age
  arm group label: bronchopulmonary dysplasia
  description: Group of patients developing bronchopulmonary dysplasia defined as the need for respiratory support at 36 weeks post-menstrual age.
  intervention type: Diagnostic Test
  intervention name: Respiratory Oscillometry
  description: Measurement of respiratory system reactance by respiratory oscillometry
  arm group label: bronchopulmonary dysplasia
  arm group label: no bronchopulmonary dysplasia
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 5 Days
  maximum age: 9 Days
  healthy volunteers: No
  last name: Camilla Rigotti, PhD
  role: Principal Investigator
  affiliation: Fondazione IRCCS San Gerardo dei Tintori
  last name: Camilla Rigotti, PhD
  phone: +39039233
  phone ext: 9173
  email: dr.camilla.rigotti@gmail.com
  last name: Emanuela Zannin, PhD
  phone: +393389323437
  email: emanuela.zannin@gmail.com
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  country: Austria
  country: Italy
  country: Netherlands
  country: Sweden
  country: Switzerland
  citation: Zannin E, Neumann RP, Dellaca R, Schulzke SM. Forced oscillation measurements in the first week of life and pulmonary outcome in very preterm infants on noninvasive respiratory support. Pediatr Res. 2019 Sep;86(3):382-388. doi: 10.1038/s41390-019-0432-6. Epub 2019 May 20.
  PMID: 31108499
  citation: Veneroni C, Wallstrom L, Sindelar R, Dellaca' RL. Oscillatory respiratory mechanics on the first day of life improves prediction of respiratory outcomes in extremely preterm newborns. Pediatr Res. 2019 Feb;85(3):312-317. doi: 10.1038/s41390-018-0133-6. Epub 2018 Aug 4.
  PMID: 30127523
  responsible party type: Sponsor
  mesh term: Bronchopulmonary Dysplasia
  sharing ipd: No