<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/NCT02223936</url>
  </required_header>
  <id_info>
    <org_study_id>2007-491</org_study_id>
    <nct_id>NCT02223936</nct_id>
  </id_info>
  <brief_title>Follow up of Neurologic Development of Children Who Presented at the First Trimester of Pregnancy an Isolated Nuchal Anomaly With Normal Karyotype</brief_title>
  <acronym>EDEN</acronym>
  <official_title>Follow up of Neurologic Development of Children Who Presented at the First Trimester of Pregnancy an Isolated Nuchal Anomaly With Normal Karyotype</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, multicenter study following for 2 years, 250 children who presented during the&#xD;
      first trimester of pregnancy an isolated nuchal translucency over the 95th percentile of&#xD;
      Nicolaïdes Curves on ultrasound and comparing them to a control group of 250 children whose&#xD;
      pregnancy was normal. Evaluating morbidity, mortality, growth and the neurodevelopment of&#xD;
      each group by a Brunet Lezine scale. Evaluating anxiety and depression in parents of those&#xD;
      children using a scale.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2009</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">February 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of developmental quotient below 70 compared to a group control</measure>
    <time_frame>Assessment at the age of 2 years + / - 45 days for each patient</time_frame>
    <description>assessed by the Brunet Lezine test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>comparison of the mean and distribution of developmental quotient between the two arms</measure>
    <time_frame>at the age of 2 years + / - 45 days</time_frame>
    <description>assessed by the Brunet Lezine test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>composite outcome measure : comparison of weight, height and head circumference between the two arms</measure>
    <time_frame>at 3 months, 1 year and 2 years</time_frame>
    <description>assessed by measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The status deceased / living and the date and cause of death if applicable</measure>
    <time_frame>any time after birth and before 2 years + / - 45 days</time_frame>
    <description>nterview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>study differences in score post-traumatic stress, anxiety and depression between parents of the two arms</measure>
    <time_frame>at the consultation at the age of 2 years + / - 45 days of the children</time_frame>
    <description>assessment of the questionnaire of posttraumatic stress and HAD scale by the parents during the consultation of the two-year child</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">500</enrollment>
  <condition>Neurological Development After Exposition to an Antenatal Nuchal Translucency</condition>
  <arm_group>
    <arm_group_label>children with Prenatal enlarged nuchal transluce</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>group exposed</intervention_name>
    <description>Assessment by Brunet Lezine scale</description>
    <arm_group_label>children with Prenatal enlarged nuchal transluce</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Not exposed group</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -&#xD;
&#xD;
        Confirmation of the enlargement of nuchal tranlucency by a sonographer referent OR&#xD;
        ultrasound abnormality neck restraint by sonographers referents replay after the initial&#xD;
        shots (the notion of transience of the pathology of the neck being allowed) with in all&#xD;
        cases:&#xD;
&#xD;
          -  gestational age between 11 and SA 13 SA 0 days 6 days or a crown-rump length between&#xD;
             45 and 84 mm&#xD;
&#xD;
          -  Thickness of the neck&gt; 95th percentile of the standard set for the crown-rump length&#xD;
             according to the team Nicolaides&#xD;
&#xD;
          -  ultrasound Clichés meet quality criteria HERMANN (score ≥ 5 at least 2 major&#xD;
             criteria).&#xD;
&#xD;
          -  normal karyotype or not done&#xD;
&#xD;
          -  Morphological Ultrasound second quarter normal or minor abnormalities&#xD;
&#xD;
               -  Consent signed holders of parental authority for monitoring up to 2 years and&#xD;
                  neurodevelopmental assessment at the end of follow-up&#xD;
&#xD;
               -  Affiliate or benefit of a social security scheme.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple Pregnancy&#xD;
&#xD;
               -  Prematurity less than 32 SA&#xD;
&#xD;
               -  Birth weight less than 1500 grams&#xD;
&#xD;
               -  Discovery of a chromosomal abnormality on karyotype not made prenatally&#xD;
&#xD;
               -  Withdrawal of consent.&#xD;
&#xD;
               -  intercurrent Event may be the cause of abnormal psychomotor development: fetal&#xD;
                  distress cause of hospitalization, prenatal viral infection&#xD;
&#xD;
        Inclusion Criteria: for control group&#xD;
&#xD;
          -  Newborn who did not have enlarged nuchal translucency and with normal antenatal&#xD;
             ultrasound.&#xD;
&#xD;
          -  Matching each child the &quot;nuchal group&quot; on:&#xD;
&#xD;
               -  Maternity Birth: matching the child witness in the University Hospital of the&#xD;
                  same region as motherhood in which the child with nuchal group is born.&#xD;
&#xD;
               -  gestational age: the child matched group must belong to the same group of&#xD;
                  gestational age than neck the child with nuchal group&#xD;
&#xD;
                    -  ≥ 37 weeks&#xD;
&#xD;
                    -  ≥ 32 and &lt;37 weeks with a less than 2 SA difference&#xD;
&#xD;
               -  Weight:&#xD;
&#xD;
                    -  if the weight of the child of nuchal group is ≥ 2500g, the weight of the&#xD;
                       child must also be matched to ≥ 2500g and with a weight difference between&#xD;
                       the two children ≤ 500g&#xD;
&#xD;
                    -  If the weight of the child of nuchal group is ≥ 1500g and less than 2500g,&#xD;
                       the weight of the child must also be matched to ≥ 1500g and less than 2500 g&#xD;
                       and with a weight difference between the two children ≤ 200g&#xD;
&#xD;
               -  Apgar score at 5 minutes: the difference in Apgar score at 5 minutes between the&#xD;
                  two children should be zero or at most equal to 1&#xD;
&#xD;
               -  birth: same according to the following criteria:&#xD;
&#xD;
                    -  primipara&#xD;
&#xD;
                    -  Multiparous&#xD;
&#xD;
          -  Consent signed holders of parental authority for neurodevelopmental assessment and&#xD;
             monitoring at the age of 2 years.&#xD;
&#xD;
          -  Children with no 21 trisomy, or other intercurrent disease may be responsible for&#xD;
             neurodevelopmental&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>26 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel BUFFIN, Dr</last_name>
    <role>Study Director</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>nuchal translucency, neurological developpment, anxiety, depression, prenatal diagnosis, normal karyotype</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</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/NCT02223936
org study id: 2007-491
nct id: NCT02223936
lead sponsor: 
has dmc: No
Prospective, multicenter study following for 2 years, 250 children who presented during the
      first trimester of pregnancy an isolated nuchal translucency over the 95th percentile of
      Nicolaïdes Curves on ultrasound and comparing them to a control group of 250 children whose
      pregnancy was normal. Evaluating morbidity, mortality, growth and the neurodevelopment of
      each group by a Brunet Lezine scale. Evaluating anxiety and depression in parents of those
      children using a scale.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Incidence of developmental quotient below 70 compared to a group control
time frame: Assessment at the age of 2 years + / - 45 days for each patient
description: assessed by the Brunet Lezine test
measure: comparison of the mean and distribution of developmental quotient between the two arms
time frame: at the age of 2 years + / - 45 days
description: assessed by the Brunet Lezine test
measure: composite outcome measure : comparison of weight, height and head circumference between the two arms
time frame: at 3 months, 1 year and 2 years
description: assessed by measurement
measure: The status deceased / living and the date and cause of death if applicable
time frame: any time after birth and before 2 years + / - 45 days
description: nterview
measure: study differences in score post-traumatic stress, anxiety and depression between parents of the two arms
time frame: at the consultation at the age of 2 years + / - 45 days of the children
description: assessment of the questionnaire of posttraumatic stress and HAD scale by the parents during the consultation of the two-year child
arm group label: children with Prenatal enlarged nuchal transluce
arm group type: Other
arm group label: Control
arm group type: Other
intervention type: Other
intervention name: group exposed
description: Assessment by Brunet Lezine scale
arm group label: children with Prenatal enlarged nuchal transluce
intervention type: Other
intervention name: Control
description: Not exposed group
arm group label: Control
criteria: 
gender: All
minimum age: N/A
maximum age: 26 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Rachel BUFFIN, Dr
role: Study Director
affiliation: Hospices Civils de Lyon
responsible party type: Sponsor
mesh term: Congenital Abnormalities