search
Back to results

Follow up of Neurologic Development of Children Who Presented at the First Trimester of Pregnancy an Isolated Nuchal Anomaly With Normal Karyotype (EDEN)

Primary Purpose

Neurological Development After Exposition to an Antenatal Nuchal Translucency

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
group exposed
Control
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Neurological Development After Exposition to an Antenatal Nuchal Translucency focused on measuring nuchal translucency, neurological developpment, anxiety, depression, prenatal diagnosis, normal karyotype

Eligibility Criteria

undefined - 26 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

-

Confirmation of the enlargement of nuchal tranlucency by a sonographer referent OR ultrasound abnormality neck restraint by sonographers referents replay after the initial shots (the notion of transience of the pathology of the neck being allowed) with in all cases:

  • gestational age between 11 and SA 13 SA 0 days 6 days or a crown-rump length between 45 and 84 mm
  • Thickness of the neck> 95th percentile of the standard set for the crown-rump length according to the team Nicolaides
  • ultrasound Clichés meet quality criteria HERMANN (score ≥ 5 at least 2 major criteria).
  • normal karyotype or not done
  • Morphological Ultrasound second quarter normal or minor abnormalities

    • Consent signed holders of parental authority for monitoring up to 2 years and neurodevelopmental assessment at the end of follow-up
    • Affiliate or benefit of a social security scheme.

Exclusion Criteria:

  • Multiple Pregnancy

    • Prematurity less than 32 SA
    • Birth weight less than 1500 grams
    • Discovery of a chromosomal abnormality on karyotype not made prenatally
    • Withdrawal of consent.
    • intercurrent Event may be the cause of abnormal psychomotor development: fetal distress cause of hospitalization, prenatal viral infection

Inclusion Criteria: for control group

  • Newborn who did not have enlarged nuchal translucency and with normal antenatal ultrasound.
  • Matching each child the "nuchal group" on:

    • Maternity Birth: matching the child witness in the University Hospital of the same region as motherhood in which the child with nuchal group is born.
    • gestational age: the child matched group must belong to the same group of gestational age than neck the child with nuchal group

      • ≥ 37 weeks
      • ≥ 32 and <37 weeks with a less than 2 SA difference
    • Weight:

      • if the weight of the child of nuchal group is ≥ 2500g, the weight of the child must also be matched to ≥ 2500g and with a weight difference between the two children ≤ 500g
      • If the weight of the child of nuchal group is ≥ 1500g and less than 2500g, the weight of the child must also be matched to ≥ 1500g and less than 2500 g and with a weight difference between the two children ≤ 200g
    • Apgar score at 5 minutes: the difference in Apgar score at 5 minutes between the two children should be zero or at most equal to 1
    • birth: same according to the following criteria:

      • primipara
      • Multiparous
  • Consent signed holders of parental authority for neurodevelopmental assessment and monitoring at the age of 2 years.
  • Children with no 21 trisomy, or other intercurrent disease may be responsible for neurodevelopmental

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    children with Prenatal enlarged nuchal transluce

    Control

    Arm Description

    Outcomes

    Primary Outcome Measures

    Incidence of developmental quotient below 70 compared to a group control
    assessed by the Brunet Lezine test

    Secondary Outcome Measures

    comparison of the mean and distribution of developmental quotient between the two arms
    assessed by the Brunet Lezine test
    composite outcome measure : comparison of weight, height and head circumference between the two arms
    assessed by measurement
    The status deceased / living and the date and cause of death if applicable
    nterview
    study differences in score post-traumatic stress, anxiety and depression between parents of the two arms
    assessment of the questionnaire of posttraumatic stress and HAD scale by the parents during the consultation of the two-year child

    Full Information

    First Posted
    August 12, 2014
    Last Updated
    August 21, 2014
    Sponsor
    Hospices Civils de Lyon
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02223936
    Brief Title
    Follow up of Neurologic Development of Children Who Presented at the First Trimester of Pregnancy an Isolated Nuchal Anomaly With Normal Karyotype
    Acronym
    EDEN
    Official Title
    Follow up of Neurologic Development of Children Who Presented at the First Trimester of Pregnancy an Isolated Nuchal Anomaly With Normal Karyotype
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2009 (undefined)
    Primary Completion Date
    February 2011 (Actual)
    Study Completion Date
    March 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospices Civils de Lyon

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neurological Development After Exposition to an Antenatal Nuchal Translucency
    Keywords
    nuchal translucency, neurological developpment, anxiety, depression, prenatal diagnosis, normal karyotype

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    500 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    children with Prenatal enlarged nuchal transluce
    Arm Type
    Other
    Arm Title
    Control
    Arm Type
    Other
    Intervention Type
    Other
    Intervention Name(s)
    group exposed
    Intervention Description
    Assessment by Brunet Lezine scale
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    Not exposed group
    Primary Outcome Measure Information:
    Title
    Incidence of developmental quotient below 70 compared to a group control
    Description
    assessed by the Brunet Lezine test
    Time Frame
    Assessment at the age of 2 years + / - 45 days for each patient
    Secondary Outcome Measure Information:
    Title
    comparison of the mean and distribution of developmental quotient between the two arms
    Description
    assessed by the Brunet Lezine test
    Time Frame
    at the age of 2 years + / - 45 days
    Title
    composite outcome measure : comparison of weight, height and head circumference between the two arms
    Description
    assessed by measurement
    Time Frame
    at 3 months, 1 year and 2 years
    Title
    The status deceased / living and the date and cause of death if applicable
    Description
    nterview
    Time Frame
    any time after birth and before 2 years + / - 45 days
    Title
    study differences in score post-traumatic stress, anxiety and depression between parents of the two arms
    Description
    assessment of the questionnaire of posttraumatic stress and HAD scale by the parents during the consultation of the two-year child
    Time Frame
    at the consultation at the age of 2 years + / - 45 days of the children

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    26 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - Confirmation of the enlargement of nuchal tranlucency by a sonographer referent OR ultrasound abnormality neck restraint by sonographers referents replay after the initial shots (the notion of transience of the pathology of the neck being allowed) with in all cases: gestational age between 11 and SA 13 SA 0 days 6 days or a crown-rump length between 45 and 84 mm Thickness of the neck> 95th percentile of the standard set for the crown-rump length according to the team Nicolaides ultrasound Clichés meet quality criteria HERMANN (score ≥ 5 at least 2 major criteria). normal karyotype or not done Morphological Ultrasound second quarter normal or minor abnormalities Consent signed holders of parental authority for monitoring up to 2 years and neurodevelopmental assessment at the end of follow-up Affiliate or benefit of a social security scheme. Exclusion Criteria: Multiple Pregnancy Prematurity less than 32 SA Birth weight less than 1500 grams Discovery of a chromosomal abnormality on karyotype not made prenatally Withdrawal of consent. intercurrent Event may be the cause of abnormal psychomotor development: fetal distress cause of hospitalization, prenatal viral infection Inclusion Criteria: for control group Newborn who did not have enlarged nuchal translucency and with normal antenatal ultrasound. Matching each child the "nuchal group" on: Maternity Birth: matching the child witness in the University Hospital of the same region as motherhood in which the child with nuchal group is born. gestational age: the child matched group must belong to the same group of gestational age than neck the child with nuchal group ≥ 37 weeks ≥ 32 and <37 weeks with a less than 2 SA difference Weight: if the weight of the child of nuchal group is ≥ 2500g, the weight of the child must also be matched to ≥ 2500g and with a weight difference between the two children ≤ 500g If the weight of the child of nuchal group is ≥ 1500g and less than 2500g, the weight of the child must also be matched to ≥ 1500g and less than 2500 g and with a weight difference between the two children ≤ 200g Apgar score at 5 minutes: the difference in Apgar score at 5 minutes between the two children should be zero or at most equal to 1 birth: same according to the following criteria: primipara Multiparous Consent signed holders of parental authority for neurodevelopmental assessment and monitoring at the age of 2 years. Children with no 21 trisomy, or other intercurrent disease may be responsible for neurodevelopmental
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rachel BUFFIN, Dr
    Organizational Affiliation
    Hospices Civils de Lyon
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Follow up of Neurologic Development of Children Who Presented at the First Trimester of Pregnancy an Isolated Nuchal Anomaly With Normal Karyotype

    We'll reach out to this number within 24 hrs