<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/NCT02996279</url>
  </required_header>
  <id_info>
    <org_study_id>100093</org_study_id>
    <nct_id>NCT02996279</nct_id>
  </id_info>
  <brief_title>Chorioamnionitis and Proinflammatory S100A12</brief_title>
  <acronym>S100A12</acronym>
  <official_title>Impact of Chorioamnionitis on Maternal and Fetal Levels of Proinflammatory S100A12</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Catholic University of the Sacred Heart</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Catholic University of the Sacred Heart</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Histologic chorioamnionitis (HCA) may lead to the fetal inflammatory response syndrome (FIRS)&#xD;
      and increased levels of proinflammatory molecules.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Histologic chorioamnionitis (HCA) may lead to the fetal inflammatory response syndrome&#xD;
      (FIRS). The aim of this pilot study was to evaluate S100A12, a marker of innate immune&#xD;
      activation, in mothers with or without HCA and in their infants.&#xD;
&#xD;
      Concentrations of S100A12, Interleukin 6 (IL-6) and C-reactive protein (CRP) were evaluated&#xD;
      in maternal, cord, and neonatal blood of very preterm infants. Histologic examinations of&#xD;
      placentae and umbilical cords were performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>S100A12 in Presence of Maternal Chorioamnionitis</measure>
    <time_frame>1 Year</time_frame>
    <description>Levels of S100A12 in Maternal, Cord and Neonatal Blood in the Presence or Absence of HCA</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">69</enrollment>
  <condition>Chorioamnionitis Affecting Fetus or Newborn</condition>
  <arm_group>
    <arm_group_label>group 1</arm_group_label>
    <description>maternal chorioamnionitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 2</arm_group_label>
    <description>no maternal chorioamnionitis</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      MATERNAL, CORD AND NEONATAL BLOOD&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Very Premature Mother-Neonate Pairs&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Preterm Birth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Congenital Abnormalities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>December 14, 2016</last_update_submitted>
  <last_update_submitted_qc>December 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Catholic University of the Sacred Heart</investigator_affiliation>
    <investigator_full_name>MARIA PIA DE CAROLIS</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Neonate</keyword>
  <keyword>Chorioamnionitis</keyword>
  <keyword>S100A12</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chorioamnionitis</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/NCT02996279
org study id: 100093
nct id: NCT02996279
lead sponsor: 
has dmc: No
Histologic chorioamnionitis (HCA) may lead to the fetal inflammatory response syndrome (FIRS)
      and increased levels of proinflammatory molecules.
Histologic chorioamnionitis (HCA) may lead to the fetal inflammatory response syndrome
      (FIRS). The aim of this pilot study was to evaluate S100A12, a marker of innate immune
      activation, in mothers with or without HCA and in their infants.

      Concentrations of S100A12, Interleukin 6 (IL-6) and C-reactive protein (CRP) were evaluated
      in maternal, cord, and neonatal blood of very preterm infants. Histologic examinations of
      placentae and umbilical cords were performed.
observational model: Cohort
time perspective: Prospective
measure: S100A12 in Presence of Maternal Chorioamnionitis
time frame: 1 Year
description: Levels of S100A12 in Maternal, Cord and Neonatal Blood in the Presence or Absence of HCA
arm group label: group 1
description: maternal chorioamnionitis
arm group label: group 2
description: no maternal chorioamnionitis
MATERNAL, CORD AND NEONATAL BLOOD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Catholic University of the Sacred Heart
investigator full name: MARIA PIA DE CAROLIS
investigator title: MD
mesh term: Chorioamnionitis
sharing ipd: No