<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/NCT01669057</url>
  </required_header>
  <id_info>
    <org_study_id>KY2011-366</org_study_id>
    <nct_id>NCT01669057</nct_id>
  </id_info>
  <brief_title>Study on Clinical Prognosis, Risk Factors and Genetic Basis of Congenital Heart Disease</brief_title>
  <acronym>SCPRFGBCHD</acronym>
  <official_title>Case-control Study on Environmental and Genetic Factors of Congenital Heart Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ningbo Women &amp; Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Changzhou Maternal and Child Care Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maternal and Child Health Hospital of Taian</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maternal and Child Health Hospital of Wuxi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kunshan City Maternal and Child Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Xiamen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maternal and Child Health Hospital, Jiading District</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Minhang Maternal and Children Health Care Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital of Fudan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to investigate the effect of parental peri-natal environmental&#xD;
      risk factors and genetic factors on the development of Congenital Heart Disease (CHD). Our&#xD;
      hypothesis is that the distributions of some environmental and genetic risk factors&#xD;
      significantly differ between neonates with and without CHD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Congenital heart defect (CHD) is one of birth defects in the structure of the heart and/or&#xD;
      great vessels. Many types of heart defects exist, most of which either obstruct blood flow in&#xD;
      the heart or vessels near it, or cause blood to flow through the heart in an abnormal&#xD;
      pattern. Heart defects are the leading cause of birth defect-related infant deaths. So far&#xD;
      people recognize that the causes of CHD are the conjunct effect of environment and genetic&#xD;
      factors, both of which remain unclear. The current stud aims at investigating all the&#xD;
      possible perinatal parental environmental risk factors and underlying genetic factors to CHD,&#xD;
      including DNA variation and methylations. A hospital-based 1:1 matched case control study is&#xD;
      conducted. Subjects were recruited through neonatal screening program, which includes a&#xD;
      clinical symptom screening followed by a cardiac ultrasound diagnosis for those with at least&#xD;
      one clinical indicator. The blood sample of participant will be collected and the parents of&#xD;
      subjects will be interviewed to completed a questionnaire including general information and&#xD;
      possible risk factors to CHD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>genome-wide DNA SNPs and methylations</measure>
    <time_frame>delivery</time_frame>
    <description>DNA sample from neonate blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>perinatal supplements and drug using</measure>
    <time_frame>three months before pregnancy till delivery</time_frame>
    <description>questionnaire including supplements and drug using for mother</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Life risk factors of mother</measure>
    <time_frame>three months before pregnancy till delivery</time_frame>
    <description>smoking, drinking, health, family history</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Life risk factors of father</measure>
    <time_frame>three months before pregnancy till delivery</time_frame>
    <description>smoking, drinking, health, family history</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gestational weeks</measure>
    <time_frame>delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>birth weight</measure>
    <time_frame>delivery</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">6000</enrollment>
  <condition>Congenital Heart Disease</condition>
  <arm_group>
    <arm_group_label>Congenital heart defect（CHD） group</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal control group</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The population is from two ongoing projects- &quot;Key Clinical Research Project Sponsored by&#xD;
        Ministry of Health Screening, evaluation and intervention of congenital heart disease in&#xD;
        newborn infants(2010-239)&quot; and &quot;Health and Public Welfare Research Project Sponsored by&#xD;
        Ministry of Health of China Screening and evaluation of congenital heart disease in&#xD;
        children of under 3 years old in the countryside(20102006)&quot;&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        case group&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Han ethnic&#xD;
&#xD;
          -  0~3 years old&#xD;
&#xD;
          -  screened by 7 indicator, diagnosed by ultrasound&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  with other brith defects&#xD;
&#xD;
          -  with Patent Ductus Arteriosus (PDA) and Patent Foramen Ovale (PFO)&#xD;
&#xD;
        Control group&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Han ethnic&#xD;
&#xD;
          -  0~3 years old&#xD;
&#xD;
          -  without any of 7 screen indicator , without CHD heart palpitations and other&#xD;
             complaints about heart disease, born in the same hospital with cases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        With other birth defects&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Children Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>201102</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>March 9, 2015</last_update_submitted>
  <last_update_submitted_qc>March 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital of Fudan University</investigator_affiliation>
    <investigator_full_name>Guoying huang</investigator_full_name>
    <investigator_title>Professor,President</investigator_title>
  </responsible_party>
  <keyword>Congenital heart disease</keyword>
  <keyword>DNA variation</keyword>
  <keyword>methylation</keyword>
  <keyword>risk factors</keyword>
  <keyword>supplements</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</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/NCT01669057
org study id: KY2011-366
nct id: NCT01669057
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The objective of this study is to investigate the effect of parental peri-natal environmental
      risk factors and genetic factors on the development of Congenital Heart Disease (CHD). Our
      hypothesis is that the distributions of some environmental and genetic risk factors
      significantly differ between neonates with and without CHD.
Congenital heart defect (CHD) is one of birth defects in the structure of the heart and/or
      great vessels. Many types of heart defects exist, most of which either obstruct blood flow in
      the heart or vessels near it, or cause blood to flow through the heart in an abnormal
      pattern. Heart defects are the leading cause of birth defect-related infant deaths. So far
      people recognize that the causes of CHD are the conjunct effect of environment and genetic
      factors, both of which remain unclear. The current stud aims at investigating all the
      possible perinatal parental environmental risk factors and underlying genetic factors to CHD,
      including DNA variation and methylations. A hospital-based 1:1 matched case control study is
      conducted. Subjects were recruited through neonatal screening program, which includes a
      clinical symptom screening followed by a cardiac ultrasound diagnosis for those with at least
      one clinical indicator. The blood sample of participant will be collected and the parents of
      subjects will be interviewed to completed a questionnaire including general information and
      possible risk factors to CHD.
observational model: Case-Control
time perspective: Cross-Sectional
measure: genome-wide DNA SNPs and methylations
time frame: delivery
description: DNA sample from neonate blood
measure: perinatal supplements and drug using
time frame: three months before pregnancy till delivery
description: questionnaire including supplements and drug using for mother
measure: Life risk factors of mother
time frame: three months before pregnancy till delivery
description: smoking, drinking, health, family history
measure: Life risk factors of father
time frame: three months before pregnancy till delivery
description: smoking, drinking, health, family history
measure: gestational weeks
time frame: delivery
measure: birth weight
time frame: delivery
arm group label: Congenital heart defect（CHD） group
arm group label: Normal control group
whole blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 3 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Children's Hospital of Fudan University
investigator full name: Guoying huang
investigator title: Professor,President
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital