<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/NCT03227536</url>
  </required_header>
  <id_info>
    <org_study_id>17-118</org_study_id>
    <nct_id>NCT03227536</nct_id>
  </id_info>
  <brief_title>Asphyxia at Birth : Causes and Neonatal Outcome</brief_title>
  <acronym>ABC-NEO</acronym>
  <official_title>Asphyxia at Birth : Evolution of Birth Asphyxia Rate, Etiologies and Neonatal Outcome From 2000 to 2016</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an historic cohort study based on the birth and delivery register of the HFME&#xD;
      maternity ward. This study aim at understanding the evolution of asphyxia at birth, at all&#xD;
      gestational ages, identifying causes and describing neonatal outcomes since 2000, when a&#xD;
      second line strategy for foetal surveillance (fetal ECG) and systematic umbilical acid-gas&#xD;
      cord blood were introduced in our maternity ward.&#xD;
&#xD;
      The investigator's hypothesis was that the neonatal asphyxia decrease could be due to 3 main&#xD;
      factors including second line strategy introduction, systematic umbilical cord acid-base&#xD;
      implementation and improvement in antenatal risk factor screening for asphyxia. The&#xD;
      investigator's second hypothesis was that neonatal prognosis in neonates with acidosis was&#xD;
      improved with systematic early after birth EEG evaluation, allowing early treatment and&#xD;
      surveillance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Neonatal asphyxia</measure>
    <time_frame>2 months</time_frame>
    <description>Neonatal asphyxia define as fetal death, neonatal death, NICU transfer, neonatal seizure, umbilical-artery blood pH ≤ 7.05 with a base deficit ≥ 12 mmol per liter, intubation for ventilation at delivery or neonatal encephalopathy</description>
  </primary_outcome>
  <enrollment type="Actual">61448</enrollment>
  <condition>Neonatal Asphyxia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All births at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2000&#xD;
        to 31 december 2016&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All births at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january&#xD;
             2000 to 31 december 2016&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants born after medical pregnancy termination and born out of the hospital and&#xD;
             secondarily hospitalized in our department will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>1 Hour</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Muriel DORET, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of obstetrics, Femme Mère Enfant Hospital</name>
      <address>
        <city>Lyon</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 11, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neonatal asphyxia</keyword>
  <keyword>neonatal acidosis</keyword>
  <keyword>fetal ECG</keyword>
  <keyword>umbilical cord acid-base status</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asphyxia Neonatorum</mesh_term>
    <mesh_term>Asphyxia</mesh_term>
  </condition_browse>
  <!-- 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/NCT03227536
org study id: 17-118
nct id: NCT03227536
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is an historic cohort study based on the birth and delivery register of the HFME
      maternity ward. This study aim at understanding the evolution of asphyxia at birth, at all
      gestational ages, identifying causes and describing neonatal outcomes since 2000, when a
      second line strategy for foetal surveillance (fetal ECG) and systematic umbilical acid-gas
      cord blood were introduced in our maternity ward.

      The investigator's hypothesis was that the neonatal asphyxia decrease could be due to 3 main
      factors including second line strategy introduction, systematic umbilical cord acid-base
      implementation and improvement in antenatal risk factor screening for asphyxia. The
      investigator's second hypothesis was that neonatal prognosis in neonates with acidosis was
      improved with systematic early after birth EEG evaluation, allowing early treatment and
      surveillance.
observational model: Cohort
time perspective: Retrospective
measure: Rate of Neonatal asphyxia
time frame: 2 months
description: Neonatal asphyxia define as fetal death, neonatal death, NICU transfer, neonatal seizure, umbilical-artery blood pH ≤ 7.05 with a base deficit ≥ 12 mmol per liter, intubation for ventilation at delivery or neonatal encephalopathy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 1 Hour
healthy volunteers: No
last name: Muriel DORET, Pr
role: Principal Investigator
affiliation: Hospices Civils de Lyon
facility: 
country: France
responsible party type: Sponsor
mesh term: Asphyxia Neonatorum
mesh term: Asphyxia