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  <citation>
    <titlStmt>
      <titl>Assessment of cognitive function in children with growth hormone deficiency and children born small for gestational age</titl>
      <IDNo>FRESH-PEF100-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="PFIZER (FRANCE)" role="">Sylvie TROY</producer>
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  <citation>
    <titlStmt>
      <titl>
                Assessment of cognitive function in children with growth hormone deficiency and children born small for gestational age            </titl>
      <altTitl>
                    méMOTS                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF100-en            </IDNo>
      <IDNo agency="PEF">
                    100                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF100                </IDNo>
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      <AuthEnty>
                    Sylvie TROY                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="PFIZER (FRANCE)">
        <ExtLink title="ROR" URI="https://ror.org/02c9yny10" role="organisation id"/>
        <ExtLink title="SIREN" URI="433623550" role="organisation id"/>
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                                    </othId>
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    <prodStmt>
      <producer role="sponsor">
                                            PFIZER (FRANCE)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="PFIZER (FRANCE)" email="sylvie.troy@pfizer.com">
                    Sylvie;TROY
                                            <ExtLink title="ROR" URI="https://ror.org/02c9yny10" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="433623550" 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>
      <keyword vocab="" vocabURI="">
                    child cognitive functions</keyword>
      <keyword vocab="" vocabURI="">
                    growth hormone</keyword>
      <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="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="cim-11">
                        Growth hormone deficiency                                            </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants: Genetic predisposition                    </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">Evaluate the level of verbal and non-verbal cognitive functions of children with a growth hormone deficiency (GHD) and children born small for the fertilization age before beginning a GH treatment. - Evaluate the percentage of GHD children and the percentage of SGA children with language cognitive function disorders. - Evaluate the percentage of GHD children and the percentage of SGA children with non-verbal cognitive function disorders. - Compare the average level of the language and non-verbal cognitive functions of GHD and SGA children to a reference population of French children. - Compare the level of verbal and non-verbal cognitive functions of GHD children and of SGA children.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2007-01-01"/>
      <collDate event="end" date="2010-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </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">Child, Preschool (2 to 5 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D002675"/>
                                                    </universe>
      <universe level="age" clusion="I">Child (6 to 12 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D002648"/>
                                                    </universe>
      <universe clusion="I">Child between the ages of 4 to 9 years, - Understanding French, - For whom the GH treatment was approved by a health insurance fund, - With an adequate supplementation of the other pituitary deficiencies in the case of a multiple deficiency.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
    </sumDscr>
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    <developmentActivity type="primary evaluation">
      <description>Quality of life/health perception</description>
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  <method>
    <dataColl>
      <timeMeth>One-time cross-sectional study</timeMeth>
      <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>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <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>
    <anlyInfo>
      <respRate>-33-</respRate>
    </anlyInfo>
    <stdyClas>Completed study</stdyClas>
  </method>
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      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
  </dataAccs>
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    <relMat>Access on specific project only</relMat>
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