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<docDscr>
  <citation>
    <titlStmt>
      <titl>Exploratory multicenter observational study to assess the outcome of infants with perinatal SARS-COV-2 infection and its link with the NO pathway: the minipuberty hypothesis</titl>
      <IDNo>FRESH-PEF73964-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)" role="">Vincent PREVOT</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Exploratory multicenter observational study to assess the outcome of infants with perinatal SARS-COV-2 infection and its link with the NO pathway: the minipuberty hypothesis            </titl>
      <altTitl>
                    miniNO-COVID                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF73964-en            </IDNo>
      <IDNo agency="PEF">
                    73964                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF73964                </IDNo>
      <IDNo agency="NCT">
                    NCT04952870                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Laurent STORME                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)">
        <ExtLink title="ROR" URI="https://ror.org/02ppyfa04" role="organisation id"/>
        <ExtLink title="SIREN" URI="265906719" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Vincent PREVOT                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)">
        <ExtLink title="ROR" URI="https://ror.org/02vjkv261" role="organisation id"/>
        <ExtLink title="SIREN" URI="180036048" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="European consortium" type="collaboration">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            EUROPEAN COMMISSION RESEARCH                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="" email="">
                    
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <topcClas vocab="health theme">
                        Endocrinology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D004704"/>
                                                </topcClas>
      <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>
      <topcClas vocab="cim-11">
                        Endocrine, nutritional or metabolic diseases                                            </topcClas>
      <topcClas vocab="cim-11">
                        Mental, behavioural or neurodevelopmental disorders                                            </topcClas>
      <topcClas vocab="cim-11">
                        Diseases of the nervous system                                            </topcClas>
      <topcClas vocab="cim-11">
                        COVID-19                                            </topcClas>
    </subject>
    <abstract contentType="purpose">To compare the follicle stimulating hormone (FSH) plasma concentrations measured at the postnatal age of 3 months between the three matched (on gestational age at birth, postnatal age and respiratory failure) newborn infants groups</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2021-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <nation abbr="de">
                    Germany
                                            <concept vocab="ISO" vocabURI="de"/>
                                    </nation>
      <nation abbr="ch">
                    Switzerland
                                            <concept vocab="ISO" vocabURI="ch"/>
                                    </nation>
      <nation abbr="gb">
                    United Kingdom
                                            <concept vocab="ISO" vocabURI="gb"/>
                                    </nation>
      <nation abbr="gr">
                    Greece
                                            <concept vocab="ISO" vocabURI="gr"/>
                                    </nation>
      <nation abbr="be">
                    Belgium
                                            <concept vocab="ISO" vocabURI="be"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients 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 level="age" clusion="I">Infant (28 days to 2 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D007223"/>
                                                    </universe>
      <universe clusion="I">o Newborn infants (24 to 41 weeks gestational age) or young infants (&lt; 3 months) admitted at the maternity ward or at the Department of Neonatology at Jeanne de Flandre Hospital, CHU of Lille with perinatal COVID-19 infection defined by: o Antenatal COVID-19 infection: pregnant women with positive PCR test at any time of the pregnancy; o Post-natal COVID-19 infection: newborn or young infants (&lt; 3 months) with positive PCR test in pharynx or stools as part of their treatment. o Newborn infants (24 to 41 weeks gestational age) or young infants (&lt; 3 months) admitted at the maternity ward or at the Department of Neonatology at Jeanne de Flandre Hospital, CHU of Lille for severe cardiorespiratory diseases requiring inhaled NO treatment. o The control group without perinatal COVID-19 infection will be matched to thevtreatment group on gestational age at birth (± 2 weeks of gestation), on postnatal age (± 3 weeks) and respiratory failure. o No inclusion in another ante- or post-natal trial; o Written consents from both parents;                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Biological data</dataKind>
    </sumDscr>
  </stdyInfo>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through independent healthcare practitioners</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Case-control study                    </notes>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Metadata-only access                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access not yet planned</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
