<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/NCT04441463</url>
  </required_header>
  <id_info>
    <org_study_id>RBHP 2020 PONS</org_study_id>
    <secondary_id>2020-A01526-33</secondary_id>
    <nct_id>NCT04441463</nct_id>
  </id_info>
  <brief_title>Simultaneous Study of the Serum Tryptase Level of the Mother and the Child During Childbirth (TryPla)</brief_title>
  <acronym>TryPla</acronym>
  <official_title>Simultaneous Study of the Serum Tryptase Level of the Mother and the Child During Childbirth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</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>
      Currently the neonatal serum level of severals proteins can be used as an indicator of&#xD;
      subsequent risk. For example, we plan to explore the neonatal kinetics of tryptase and other&#xD;
      immune proteins as potential markers for the risk of postnatal complications, particularly in&#xD;
      premature babies. However, today no study has shown whether the tryptase level in the newborn&#xD;
      is a reflection of fetal synthesis alone, or that of the mother by possible transplacental&#xD;
      passage. There is also no database that has defined normal values for tryptase in cord blood.&#xD;
&#xD;
      Our main objective is to determine the correlation between the level of maternal tryptase and&#xD;
      that of the newborn in cord blood immediately after birth in order to estimate the&#xD;
      transplacental passage of this molecule.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  The protocole will be explain to the family in delivery room, an information note will&#xD;
           be given, and we will let the time to think about it.&#xD;
&#xD;
        -  In a second time investigator will make the mother sign a consent, that participant&#xD;
           could retract any time then.&#xD;
&#xD;
        -  A blood sample will be taken from the mother within 2 hours of delivery, using a&#xD;
           standard blood test.&#xD;
&#xD;
        -  A sample will be taken from the infant by blood drawn from the umbilical cord&#xD;
           (non-invasive and painless sample).&#xD;
&#xD;
        -  A final blood sample from your newborn will be collected at the time of the Guthrie test&#xD;
           (systematic screening for congenital diseases) already scheduled for the new born on the&#xD;
           third day of life.&#xD;
&#xD;
        -  This blood sample will be sent to the immunology laboratory of the Clermont-Ferrand&#xD;
           University Hospital where specific biological assays will be carried out.&#xD;
&#xD;
        -  Blood samples will be stored for future use in studies.&#xD;
&#xD;
        -  A collection of data concerning the child, childbirth and the results of biological&#xD;
           analyzes will be carried out. All data will be coded.&#xD;
&#xD;
        -  A phone call will be made at 3 months of life, to review the state of the child's health&#xD;
           during his first months of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of blood tryptase</measure>
    <time_frame>at birth (day 0)</time_frame>
    <description>blood sample for biomarker reflecting the mast cell activity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of blood tryptase</measure>
    <time_frame>day 3</time_frame>
    <description>blood sampling for biomarker reflecting the mast cell activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of infectious disease and hospitalization</measure>
    <time_frame>Month 3</time_frame>
    <description>call phone for evaluation of medical condition for child by questionnaire about physical history in the past 3 months</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Newborn</condition>
  <condition>Parturient</condition>
  <arm_group>
    <arm_group_label>cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mother-child couple</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood sampling for tryptase analysis</intervention_name>
    <description>3 bloods test&#xD;
One blood sample taking from the mother's vein punction, during the delivery.&#xD;
One blood sample tanking from umbilical cord.&#xD;
One blood sample taking from the baby in day 3 of life, during the Guthrie test.</description>
    <arm_group_label>cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mother-child couple&#xD;
&#xD;
          -  Childbirth at the Clermont-Ferrand University Hospital.&#xD;
&#xD;
          -  Affiliated to a social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Newborns whose holders of parental authority are protected by law (under guardianship,&#xD;
             placed under the protection of justice)&#xD;
&#xD;
          -  Newborns whose holders of parental authority are under the age of 18&#xD;
&#xD;
          -  Fetal pathology, excluding prematurity.&#xD;
&#xD;
          -  emergency caesarean section, because o life threatening condition for the fetus or the&#xD;
             mother.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maguelonne Pons</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lise LACLAUTRE</last_name>
    <phone>+33473754963</phone>
    <email>promo_interne_drci@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Lise Laclautre</last_name>
      <phone>+33473754963</phone>
      <email>promo_interne_drci@chu-clermontferrand.fr</email>
    </contact>
    <investigator>
      <last_name>Maguelonne Pons</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tryptase</keyword>
  <keyword>Neonatal</keyword>
  <keyword>Newborn</keyword>
  <keyword>Transplacental passage</keyword>
  <keyword>Mast cell</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Biomarker</keyword>
  <!-- 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/NCT04441463
org study id: RBHP 2020 PONS
secondary id: 2020-A01526-33
nct id: NCT04441463
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Currently the neonatal serum level of severals proteins can be used as an indicator of
      subsequent risk. For example, we plan to explore the neonatal kinetics of tryptase and other
      immune proteins as potential markers for the risk of postnatal complications, particularly in
      premature babies. However, today no study has shown whether the tryptase level in the newborn
      is a reflection of fetal synthesis alone, or that of the mother by possible transplacental
      passage. There is also no database that has defined normal values for tryptase in cord blood.

      Our main objective is to determine the correlation between the level of maternal tryptase and
      that of the newborn in cord blood immediately after birth in order to estimate the
      transplacental passage of this molecule.
-  The protocole will be explain to the family in delivery room, an information note will
           be given, and we will let the time to think about it.

        -  In a second time investigator will make the mother sign a consent, that participant
           could retract any time then.

        -  A blood sample will be taken from the mother within 2 hours of delivery, using a
           standard blood test.

        -  A sample will be taken from the infant by blood drawn from the umbilical cord
           (non-invasive and painless sample).

        -  A final blood sample from your newborn will be collected at the time of the Guthrie test
           (systematic screening for congenital diseases) already scheduled for the new born on the
           third day of life.

        -  This blood sample will be sent to the immunology laboratory of the Clermont-Ferrand
           University Hospital where specific biological assays will be carried out.

        -  Blood samples will be stored for future use in studies.

        -  A collection of data concerning the child, childbirth and the results of biological
           analyzes will be carried out. All data will be coded.

        -  A phone call will be made at 3 months of life, to review the state of the child's health
           during his first months of life.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Rate of blood tryptase
time frame: at birth (day 0)
description: blood sample for biomarker reflecting the mast cell activity
measure: Rate of blood tryptase
time frame: day 3
description: blood sampling for biomarker reflecting the mast cell activity
measure: Incidence of infectious disease and hospitalization
time frame: Month 3
description: call phone for evaluation of medical condition for child by questionnaire about physical history in the past 3 months
arm group label: cohort
arm group type: Experimental
description: Mother-child couple
intervention type: Biological
intervention name: Blood sampling for tryptase analysis
description: 3 bloods test
One blood sample taking from the mother's vein punction, during the delivery.
One blood sample tanking from umbilical cord.
One blood sample taking from the baby in day 3 of life, during the Guthrie test.
arm group label: cohort
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Maguelonne Pons
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: Lise LACLAUTRE
phone: +33473754963
email: promo_interne_drci@chu-clermontferrand.fr
facility: 
contact: 
investigator: 
country: France
responsible party type: Sponsor