xml: <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/NCT06021691</url>
    </required_header>
    <id_info>
      <org_study_id>NCRCCHD-2022-GP-17</org_study_id>
      <nct_id>NCT06021691</nct_id>
    </id_info>
    <brief_title>Gestational Diabetes Mother-infant Cohort</brief_title>
    <official_title>A Cohort Study on the Impact of Gestational Blood Glucose Management and Postnatal Nurturing Environment on Delayed Language Development in Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gansu Provincial Maternal and Child Health Care Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gansu Provincial Maternal and Child Health Care Hospital</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>
        The bi-directional dynamic cohort study is to learn about the effects of prenatal exposure to&#xD;
        high blood glucose levels and postnatal nurturing environment factors on delayed language&#xD;
        development in children. The study investigated the results of blood glucose screening during&#xD;
        pregnancy for the children's mothers, and followed up on the blood glucose management&#xD;
        effectiveness of pregnant women with abnormal blood glucose levels before delivery.&#xD;
        Participants will be also surveyed the &quot;S-S method for language development assessment,&#xD;
        &quot;gsell Scale&quot;, and &quot;0-6 year-old family nurturing environment evaluation scale&quot; to evaluate&#xD;
        the language development and family nurturing environment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Glucose management during pregnancy and the postnatal nurturing environment are keys to early&#xD;
        detection and early intervention of language delay, which is important to reduce abnormal&#xD;
        language development in children. In this study, mothers diagnosed with gestational diabetes&#xD;
        mellitus in the department of hospital and offspring were used as participants. The&#xD;
        investigators take a follow-up visit to participants' offspring using the S-S method of&#xD;
        language development assessment, gsell Infant and Toddler Development Scale, and 0-6 years&#xD;
        old family parenting environment evaluation scale. The bi-directional dynamic cohort study is&#xD;
        to learn about the effects of prenatal exposure to high blood glucose levels and postnatal&#xD;
        nurturing environment factors on delayed language development in children.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2025</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>delayed language development in children</measure>
      <time_frame>2023.1-2025.11</time_frame>
      <description>&quot;Number of participants diagnosed with GDM,&quot; &quot;Number of offspring of participants who participated in the survey of family nurturing environments,&quot; and &quot;Composition ratio of offspring with GDM who presented with language delays.&quot;</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">600</enrollment>
    <condition>Gestational Diabetes Mellitus in Pregnancy</condition>
    <condition>Cognitive Impairment</condition>
    <condition>Cohort Study</condition>
    <arm_group>
      <arm_group_label>Gestational diabetes offspring cohort</arm_group_label>
      <description>The Gestational diabetes(GDM) offspring cohort is to learn about language development assessment in 2-year-old children and causal association with their mother who diagnosed GDM</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy maternal offspring cohort</arm_group_label>
      <description>Healthy maternal offspring cohort is to learn about language development assessment in 2-year-old children and causal association with their health mother</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Acquired nurturing environment</intervention_name>
      <description>Superimposed effects of intrauterine high-sugar environment exposure and postnatal nurturing environment exposure</description>
      <arm_group_label>Gestational diabetes offspring cohort</arm_group_label>
      <arm_group_label>Healthy maternal offspring cohort</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Collection of maternal peripheral blood during pregnancy and umbilical cord blood at delivery&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          The pregnant women with abnormal blood glucose levels and the offspring&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children 1.5-2.5 years old with no serious underlying diseases and no hearing&#xD;
               impairment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  diagnosed hearing impairment, organic dysarthria, oral disease; (ii) cerebral palsy;&#xD;
  &#xD;
            -  neurological and hereditary metabolic diseases; (iv) deaf father/mother.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>3 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Cheng Wang</last_name>
      <role>Principal Investigator</role>
      <affiliation>Gansu Provincial Maternal and Child Health Care Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yanxia Wang, Dr.</last_name>
      <phone>86-0931-5188689</phone>
      <email>1091771450@qq.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>GansuPMCH</name>
        <address>
          <city>Lanzhou</city>
          <state>Gansu</state>
          <zip>730050</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yanxia Wang, Dr.</last_name>
        <phone>13893210796</phone>
        <email>1091771450@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Child cognitive impairment</keyword>
    <keyword>Intrauterine high-glucose environment</keyword>
    <keyword>Acquired nurture environment</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes, Gestational</mesh_term>
      <mesh_term>Pregnancy in Diabetics</mesh_term>
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>April 20, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT06021691/Prot_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06021691
  org study id: NCRCCHD-2022-GP-17
  nct id: NCT06021691
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The bi-directional dynamic cohort study is to learn about the effects of prenatal exposure to
        high blood glucose levels and postnatal nurturing environment factors on delayed language
        development in children. The study investigated the results of blood glucose screening during
        pregnancy for the children's mothers, and followed up on the blood glucose management
        effectiveness of pregnant women with abnormal blood glucose levels before delivery.
        Participants will be also surveyed the "S-S method for language development assessment,
        "gsell Scale", and "0-6 year-old family nurturing environment evaluation scale" to evaluate
        the language development and family nurturing environment.
  Glucose management during pregnancy and the postnatal nurturing environment are keys to early
        detection and early intervention of language delay, which is important to reduce abnormal
        language development in children. In this study, mothers diagnosed with gestational diabetes
        mellitus in the department of hospital and offspring were used as participants. The
        investigators take a follow-up visit to participants' offspring using the S-S method of
        language development assessment, gsell Infant and Toddler Development Scale, and 0-6 years
        old family parenting environment evaluation scale. The bi-directional dynamic cohort study is
        to learn about the effects of prenatal exposure to high blood glucose levels and postnatal
        nurturing environment factors on delayed language development in children.
  observational model: Cohort
  time perspective: Prospective
  measure: delayed language development in children
  time frame: 2023.1-2025.11
  description: "Number of participants diagnosed with GDM," "Number of offspring of participants who participated in the survey of family nurturing environments," and "Composition ratio of offspring with GDM who presented with language delays."
  arm group label: Gestational diabetes offspring cohort
  description: The Gestational diabetes(GDM) offspring cohort is to learn about language development assessment in 2-year-old children and causal association with their mother who diagnosed GDM
  arm group label: Healthy maternal offspring cohort
  description: Healthy maternal offspring cohort is to learn about language development assessment in 2-year-old children and causal association with their health mother
  intervention type: Behavioral
  intervention name: Acquired nurturing environment
  description: Superimposed effects of intrauterine high-sugar environment exposure and postnatal nurturing environment exposure
  arm group label: Gestational diabetes offspring cohort
  arm group label: Healthy maternal offspring cohort
  Collection of maternal peripheral blood during pregnancy and umbilical cord blood at delivery
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: 3 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Cheng Wang
  role: Principal Investigator
  affiliation: Gansu Provincial Maternal and Child Health Care Hospital
  last name: Yanxia Wang, Dr.
  phone: 86-0931-5188689
  email: 1091771450@qq.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Diabetes, Gestational
  mesh term: Pregnancy in Diabetics
  mesh term: Cognitive Dysfunction
  provided document: 