<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/NCT04401540</url>
  </required_header>
  <id_info>
    <org_study_id>NICU-COVID-TR</org_study_id>
    <nct_id>NCT04401540</nct_id>
  </id_info>
  <brief_title>Characteristics of Neonatal Covid-19 in Turkey</brief_title>
  <official_title>Clinical and Epidemiological Characteristics of COVID-19 Infection on Babies of Prenatal COVID-19 Positive Women in Turkey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Recep Tayyip Erdogan University Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Turkish Neonatal Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Recep Tayyip Erdogan University Training and Research Hospital</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 investigators aimed to investigate the clinical and epidemiological characteristics of&#xD;
      neonates who will be born to Covid-19 positive mothers in Turkey. It is a multicentric&#xD;
      prospective cohort study designed and destined only in Turkey. The investigators are planning&#xD;
      to admit more than 20 Neonatal Intensive Care Units into the survey; nevertheless, the total&#xD;
      number may change according to the prevalence of Covid-19 in neonates.&#xD;
&#xD;
      The investigators will also inquire into vertical transmission by collecting cord blood,&#xD;
      placental, and postnatal serum samples to test for Covid-19 PCR and Covid-19 Ig M and IgG&#xD;
      values from the neonates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients will be recruited by a secure database of &quot;Trials Network&quot; with individualized&#xD;
      accounts. Plexus Corporation will hold data monitoring and primary analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Vertical Transmission</measure>
    <time_frame>First 28 days of life</time_frame>
    <description>Vertical transmission will be investigated by obtaining neonatal PCR samples in blood, stool and mother milk as well as Neonatal Covid-19 Ig M and Ig G values</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>First 28 days of life</time_frame>
    <description>Hospital span time of the neonates in NICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early neonatal sepsis rate</measure>
    <time_frame>First 3 days</time_frame>
    <description>Early neonatal sepsis rate</description>
  </secondary_outcome>
  <enrollment type="Anticipated">90</enrollment>
  <condition>COVID-19</condition>
  <condition>Neonatal Disease</condition>
  <condition>Healthy</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Nasopharyngeal, endotracheal aspirates of the neonate for Covid-19 Placenta and blood and&#xD;
      stool samples of the neonate Milk of the mother&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators will try to recruit all the babies that will be born to mothers with&#xD;
        Covid-19 disease across Turkey.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants born to mothers with Covid-19 infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If PCR values of mother negative, even though the clinic is preferable for Covid-19,&#xD;
             the infant will not be recruited.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>28 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mehmet K Kanburoglu, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Head of Pediatrics and Neonatology, Associate Professor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mehmet K Kanburoglu, M.D.</last_name>
    <phone>+905326685916</phone>
    <email>kanburoglumk@outlook.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mehmet Y Oncel, M.D.</last_name>
    <phone>+90532 631 51 85</phone>
    <email>dryekta@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Recep Tayyip Erdogan University Medical School</name>
      <address>
        <city>Rize</city>
        <zip>53200</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mehmet K Kanburoglu, M.D.</last_name>
      <phone>+905326685916</phone>
      <email>kanburoglumk@outlook.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Karimi-Zarchi M, Neamatzadeh H, Dastgheib SA, Abbasi H, Mirjalili SR, Behforouz A, Ferdosian F, Bahrami R. Vertical Transmission of Coronavirus Disease 19 (COVID-19) from Infected Pregnant Mothers to Neonates: A Review. Fetal Pediatr Pathol. 2020 Jun;39(3):246-250. doi: 10.1080/15513815.2020.1747120. Epub 2020 Apr 2.</citation>
    <PMID>32238084</PMID>
  </results_reference>
  <results_reference>
    <citation>Mimouni F, Lakshminrusimha S, Pearlman SA, Raju T, Gallagher PG, Mendlovic J. Perinatal aspects on the covid-19 pandemic: a practical resource for perinatal-neonatal specialists. J Perinatol. 2020 May;40(5):820-826. doi: 10.1038/s41372-020-0665-6. Epub 2020 Apr 10.</citation>
    <PMID>32277162</PMID>
  </results_reference>
  <results_reference>
    <citation>Liu W, Wang J, Li W, Zhou Z, Liu S, Rong Z. Clinical characteristics of 19 neonates born to mothers with COVID-19. Front Med. 2020 Apr;14(2):193-198. doi: 10.1007/s11684-020-0772-y. Epub 2020 Apr 13.</citation>
    <PMID>32285380</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 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>Recep Tayyip Erdogan University Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Mehmet Kenan Kanburoglu</investigator_full_name>
    <investigator_title>Associate Professor of Pediatrics, Neonatologist, Head of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Vertical Transmission</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Infant, Newborn, Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>all IPD that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>starting 6 months after publication</ipd_time_frame>
    <ipd_access_criteria>The data will be shared in case of review requests from investigators who have an ORCHID account.</ipd_access_criteria>
  </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/NCT04401540
org study id: NICU-COVID-TR
nct id: NCT04401540
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators aimed to investigate the clinical and epidemiological characteristics of
      neonates who will be born to Covid-19 positive mothers in Turkey. It is a multicentric
      prospective cohort study designed and destined only in Turkey. The investigators are planning
      to admit more than 20 Neonatal Intensive Care Units into the survey; nevertheless, the total
      number may change according to the prevalence of Covid-19 in neonates.

      The investigators will also inquire into vertical transmission by collecting cord blood,
      placental, and postnatal serum samples to test for Covid-19 PCR and Covid-19 Ig M and IgG
      values from the neonates.
The patients will be recruited by a secure database of "Trials Network" with individualized
      accounts. Plexus Corporation will hold data monitoring and primary analysis.
observational model: Cohort
time perspective: Prospective
measure: Vertical Transmission
time frame: First 28 days of life
description: Vertical transmission will be investigated by obtaining neonatal PCR samples in blood, stool and mother milk as well as Neonatal Covid-19 Ig M and Ig G values
measure: Hospital stay
time frame: First 28 days of life
description: Hospital span time of the neonates in NICU
measure: Early neonatal sepsis rate
time frame: First 3 days
description: Early neonatal sepsis rate
Nasopharyngeal, endotracheal aspirates of the neonate for Covid-19 Placenta and blood and
      stool samples of the neonate Milk of the mother
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 28 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Mehmet K Kanburoglu, M.D.
role: Study Director
affiliation: Head of Pediatrics and Neonatology, Associate Professor
last name: Mehmet K Kanburoglu, M.D.
phone: +905326685916
email: kanburoglumk@outlook.com
last name: Mehmet Y Oncel, M.D.
phone: +90532 631 51 85
email: dryekta@gmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
citation: Karimi-Zarchi M, Neamatzadeh H, Dastgheib SA, Abbasi H, Mirjalili SR, Behforouz A, Ferdosian F, Bahrami R. Vertical Transmission of Coronavirus Disease 19 (COVID-19) from Infected Pregnant Mothers to Neonates: A Review. Fetal Pediatr Pathol. 2020 Jun;39(3):246-250. doi: 10.1080/15513815.2020.1747120. Epub 2020 Apr 2.
PMID: 32238084
citation: Mimouni F, Lakshminrusimha S, Pearlman SA, Raju T, Gallagher PG, Mendlovic J. Perinatal aspects on the covid-19 pandemic: a practical resource for perinatal-neonatal specialists. J Perinatol. 2020 May;40(5):820-826. doi: 10.1038/s41372-020-0665-6. Epub 2020 Apr 10.
PMID: 32277162
citation: Liu W, Wang J, Li W, Zhou Z, Liu S, Rong Z. Clinical characteristics of 19 neonates born to mothers with COVID-19. Front Med. 2020 Apr;14(2):193-198. doi: 10.1007/s11684-020-0772-y. Epub 2020 Apr 13.
PMID: 32285380
responsible party type: Principal Investigator
investigator affiliation: Recep Tayyip Erdogan University Training and Research Hospital
investigator full name: Mehmet Kenan Kanburoglu
investigator title: Associate Professor of Pediatrics, Neonatologist, Head of Pediatrics
mesh term: COVID-19
mesh term: Infant, Newborn, Diseases
sharing ipd: Yes
ipd description: all IPD that underlie results in a publication
ipd info type: Study Protocol
ipd time frame: starting 6 months after publication
ipd access criteria: The data will be shared in case of review requests from investigators who have an ORCHID account.