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<docDscr>
  <citation>
    <titlStmt>
      <titl>Autonomic maturation in neonatal period and early neurologic development: perspective longitudinal cohort study</titl>
      <IDNo>FRESH-PEF3658-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE" role="">Jean-Claude BARTHELEMY</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Autonomic maturation in neonatal period and early neurologic development: perspective longitudinal cohort study            </titl>
      <altTitl>
                    AUBE                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF3658-en            </IDNo>
      <IDNo agency="PEF">
                    3658                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF3658                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Jean-Claude BARTHELEMY                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE">
        <ExtLink title="ROR" URI="https://ror.org/04pn6vp43" role="organisation id"/>
        <ExtLink title="SIREN" URI="264200304" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Hugues PATURAL                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE">
        <ExtLink title="ROR" URI="https://ror.org/04pn6vp43" role="organisation id"/>
        <ExtLink title="SIREN" URI="264200304" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Georges TEYSSIER                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE">
        <ExtLink title="ROR" URI="https://ror.org/04pn6vp43" role="organisation id"/>
        <ExtLink title="SIREN" URI="264200304" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE" email="hugues.patural@chu-st-etienne.fr">
                    Hugues;PATURAL
                                            <ExtLink title="ROR" URI="https://ror.org/04pn6vp43" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="264200304" role="organisation id"/>
                                    </contact>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE" email="georges.teyssier@chu-st-etienne.fr">
                    Georges;TEYSSIER
                                            <ExtLink title="ROR" URI="https://ror.org/04pn6vp43" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="264200304" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <topcClas vocab="health theme">
                        Neurology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"/>
                                                            <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D009462"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Paediatrics                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D010372"/>
                                                </topcClas>
    </subject>
    <abstract contentType="purpose">Describe the profile of maturation of the autonomic cardiac system (through time and frequency analysis of the heart rate variability from polysomnographic 24 hours records) during the firsts two years of life (0, 6, 12, 18 and 24 months) in a full-term or premature infants cohort. Secondary objectives: - Correlate in this cohort the autonomic status at birth and the neurological psychomotor becoming at 2 years; - Describe autonomic evolution profile during the firsts two years of life; - According to specific pregnancy criteria; - According to morphometry data; - According to respiratory, cardiac, neurological, digestive, infectious neonatal morbidity criteria; - According to the incidence of severe diseases and rhythmic disorders during the two firsts two years of life.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2009-01-01"/>
      <collDate event="end" date="2013-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogCover>Auvergne Rhône-Alpes</geogCover>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">General population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Infant, Newborn (birth to 28 days)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D007231"/>
                                                    </universe>
      <universe clusion="I">Every child born at the CHU of Saint Etienne, regardless of the terms of birth, hospitalized in a neonatal unit at the moment of the recording (after 37 corrected weeks in case of prematurity) or at the maternity ward.  - Signature of the written consent by the parents or the legal guardians.  - Parents or legal guardians, affiliated to social security or right-holder.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Paraclinical data (non-biological) : Function testing</dataKind>
    </sumDscr>
    <qualityStatement>
      <otherQualityStatement>Coherence request after computer data entry. Missing data asked back to the patient or a third. Doctors remainders for follow-up visits. Internal quality audit reports every 6 months. Internal audit frequency: Statistics</otherQualityStatement>
      <otherQualityStatement>by data themes. External audit frequency: 3. EIG declaration (serious adverse effects). Patients receive information about the use of their data.</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[500-1000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Self-administered questionnaire                                                            <concept vocab="CESSDA" vocabURI="SelfAdministeredQuestionnaire"/>
                                                    </collMode>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>6400</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <restrctn>Data utilization for academic teams and for industrials to be determined.</restrctn>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
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