<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/NCT04470739</url>
  </required_header>
  <id_info>
    <org_study_id>KSSEAH--CT</org_study_id>
    <nct_id>NCT04470739</nct_id>
  </id_info>
  <brief_title>Is Thymus Size of Infants Who Born to COVID-19 Positive Mothers Associated With Neonatal Morbidities?</brief_title>
  <official_title>Is Thymus Size of Infants Who Born to COVID-19 Positive Mothers Associated With Neonatal Morbidities?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kanuni Sultan Suleyman Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kanuni Sultan Suleyman Training and Research 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>
      COVID-19 infected pregnant women is thought to have variable degrees of inflammatory response&#xD;
      against the disease. Investigators of present study, suggested that fetuses are affected from&#xD;
      the possible fetal inflammatory syndrome in case of maternal COVID-19. Therefore the aim of&#xD;
      his study is to evaluate that if the cardiothymic index is affected by the maternal COVID-19&#xD;
      and to demonstrate any possible association of this measurement with neonatal morbidities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID-19 infected pregnant women is thought to have variable degrees of inflammatory response&#xD;
      against the disease. Fetus is known to be influenced by maternal systemic infections. Thymus&#xD;
      size of fetus and the neonate, is proven to be changed by primarily inflammatory/infectious&#xD;
      diseases. Investigators of present study, suggested that fetuses are affected from the&#xD;
      possible fetal inflammatory syndrome in case of maternal COVID-19. Therefore the aim of his&#xD;
      study is to evaluate that if the cardiothymic index is affected by the maternal COVID-19 and&#xD;
      to demonstrate any possible association of this measurement with neonatal morbidities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 30, 2020</start_date>
  <completion_date type="Anticipated">October 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiothymic index</measure>
    <time_frame>4 months</time_frame>
    <description>Cardiothymic index will be measured by using the thymic shadow divided by largest diameter of mediastinum in the chest X-ray of those infants.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immune profile</measure>
    <time_frame>6 months</time_frame>
    <description>In long term follow up of those patients, infants will be evaluated for any kind of immune deficiency or quantitative or qualitative abnormalities of leukocytes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Covid19</condition>
  <condition>Thymic Hypoplasia</condition>
  <arm_group>
    <arm_group_label>Infants born to COVID-19 positive mothers</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Infants, born to COVID-19 positive mothers, will be evaluated for cardiothymic index in their first chest X-ray.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infants born to COVID-19 negative mothers</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Infants, born to COVID-19 negative mothers, will be evaluated for cardiothymic index in their first chest X-ray.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>chest x-ray</intervention_name>
    <description>First Chest X-ray in the first 6 hours of infants</description>
    <arm_group_label>Infants born to COVID-19 positive mothers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants born to COVID-19 positive or negative mothers&#xD;
&#xD;
          -  Accepted to participate with an informed consent&#xD;
&#xD;
          -  Infants who required to get chest X-ray within the first 6 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants whose mothers' have any kind of acute or chronic systemic disease or&#xD;
             inflammation/infection&#xD;
&#xD;
          -  Lack of an informed consent&#xD;
&#xD;
          -  Infants who did not require to get chest X-ray within the first 6 hours&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>7 Hours</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Seda Yilmaz Semerci</last_name>
    <phone>+905337180683</phone>
    <email>sedayilmazsemerci@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kanuni Sultan Suleyman Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34303</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Seda Yilmaz Semerci</last_name>
      <phone>+905337180683</phone>
      <email>sedayilmazsemerci@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kanuni Sultan Suleyman Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Seda Yilmaz Semerci</investigator_full_name>
    <investigator_title>Neonatologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04470739
org study id: KSSEAH--CT
nct id: NCT04470739
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
COVID-19 infected pregnant women is thought to have variable degrees of inflammatory response
      against the disease. Investigators of present study, suggested that fetuses are affected from
      the possible fetal inflammatory syndrome in case of maternal COVID-19. Therefore the aim of
      his study is to evaluate that if the cardiothymic index is affected by the maternal COVID-19
      and to demonstrate any possible association of this measurement with neonatal morbidities.
COVID-19 infected pregnant women is thought to have variable degrees of inflammatory response
      against the disease. Fetus is known to be influenced by maternal systemic infections. Thymus
      size of fetus and the neonate, is proven to be changed by primarily inflammatory/infectious
      diseases. Investigators of present study, suggested that fetuses are affected from the
      possible fetal inflammatory syndrome in case of maternal COVID-19. Therefore the aim of his
      study is to evaluate that if the cardiothymic index is affected by the maternal COVID-19 and
      to demonstrate any possible association of this measurement with neonatal morbidities.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Cardiothymic index
time frame: 4 months
description: Cardiothymic index will be measured by using the thymic shadow divided by largest diameter of mediastinum in the chest X-ray of those infants.
measure: Immune profile
time frame: 6 months
description: In long term follow up of those patients, infants will be evaluated for any kind of immune deficiency or quantitative or qualitative abnormalities of leukocytes
arm group label: Infants born to COVID-19 positive mothers
arm group type: Active Comparator
description: Infants, born to COVID-19 positive mothers, will be evaluated for cardiothymic index in their first chest X-ray.
arm group label: Infants born to COVID-19 negative mothers
arm group type: No Intervention
description: Infants, born to COVID-19 negative mothers, will be evaluated for cardiothymic index in their first chest X-ray.
intervention type: Diagnostic Test
intervention name: chest x-ray
description: First Chest X-ray in the first 6 hours of infants
arm group label: Infants born to COVID-19 positive mothers
criteria: 
gender: All
minimum age: N/A
maximum age: 7 Hours
healthy volunteers: Accepts Healthy Volunteers
last name: Seda Yilmaz Semerci
phone: +905337180683
email: sedayilmazsemerci@gmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kanuni Sultan Suleyman Training and Research Hospital
investigator full name: Seda Yilmaz Semerci
investigator title: Neonatologist
mesh term: COVID-19
sharing ipd: No