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/NCT06031324</url>
    </required_header>
    <id_info>
      <org_study_id>BCH-2023-14/2</org_study_id>
      <nct_id>NCT06031324</nct_id>
    </id_info>
    <brief_title>The Role of Lung Ultrasonography Score in Predicting Prognosis in Term and Late Preterm Newborns With Postnatal Respiratory Distress</brief_title>
    <acronym>TeLaPLUS</acronym>
    <official_title>The Role of Lung Ultrasonography Score in Predicting Prognosis in Term and Late Preterm Newborns With Postnatal Respiratory Distress</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bursa City Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bursa City Hospital</source>
    <oversight_info>
      <has_dmc>No</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>
        Respiratory distress in term and late preterm infants in the first hour after birth is a&#xD;
        prevalent condition. This situation may occur due to different reasons such as minimal&#xD;
        respiratory stress, transient tachypnea of newborn, respiratory distress syndrome, and&#xD;
        congenital pneumonia. It can be not easy to distinguish this in the first hours. This study&#xD;
        aimed to investigate the place of the lung ultrasonography score in the prognosis of these&#xD;
        patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 11, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Enrollment of a targeted number of patients</measure>
      <time_frame>4 months</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Respiratory Distress Syndrome</condition>
    <condition>Transient Tachypnea of Newborn</condition>
    <condition>Lung Ultrasonography Score</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Term and late-preterm premature newborns with respiratory distress symptoms in the first 30&#xD;
          minutes after birth&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having symptoms of respiratory distress that begin soon after birth,&#xD;
  &#xD;
            -  &gt; 34 gestational age,&#xD;
  &#xD;
            -  &gt;1900 gr birth weight,&#xD;
  &#xD;
            -  Family consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Congenital anomaly&#xD;
  &#xD;
            -  Chromosomal anomaly&#xD;
  &#xD;
            -  Hydrops fetalis&#xD;
  &#xD;
            -  Congenital heart disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Minutes</minimum_age>
      <maximum_age>120 Minutes</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Bayram Ali Dorum</last_name>
      <phone>+905337078398</phone>
      <email>bayramalidorum@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ayten Erdoğan Ordu</last_name>
      <email>aytenli21@hotmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Bursa City Hospital</name>
        <address>
          <city>Bursa</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bayram Ali Dorum</last_name>
        <email>bayramalidorum@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Ayten Erdogan Ordu</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Bensu Zadeoglu</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Bursa City Hospital</investigator_affiliation>
      <investigator_full_name>Bayram Ali DORUM</investigator_full_name>
      <investigator_title>Associate Professor of Neonatology</investigator_title>
    </responsible_party>
    <keyword>Respiratory distress syndrome</keyword>
    <keyword>Lung ultrasonography</keyword>
    <keyword>Newborn</keyword>
    <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>Tachypnea</mesh_term>
      <mesh_term>Transient Tachypnea of the Newborn</mesh_term>
    </condition_browse>
    <!-- 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/NCT06031324
  org study id: BCH-2023-14/2
  nct id: NCT06031324
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Respiratory distress in term and late preterm infants in the first hour after birth is a
        prevalent condition. This situation may occur due to different reasons such as minimal
        respiratory stress, transient tachypnea of newborn, respiratory distress syndrome, and
        congenital pneumonia. It can be not easy to distinguish this in the first hours. This study
        aimed to investigate the place of the lung ultrasonography score in the prognosis of these
        patients.
  observational model: Case-Control
  time perspective: Prospective
  measure: Enrollment of a targeted number of patients
  time frame: 4 months
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 30 Minutes
  maximum age: 120 Minutes
  last name: Bayram Ali Dorum
  phone: +905337078398
  email: bayramalidorum@gmail.com
  last name: Ayten Erdoğan Ordu
  email: aytenli21@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Bursa City Hospital
  investigator full name: Bayram Ali DORUM
  investigator title: Associate Professor of Neonatology
  mesh term: Respiratory Distress Syndrome
  mesh term: Respiratory Distress Syndrome, Newborn
  mesh term: Tachypnea
  mesh term: Transient Tachypnea of the Newborn