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

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.

Study Overview

• Status: Completed
• Conditions: Neurological Development After Exposition to an Antenatal Nuchal Translucency
• Intervention / Treatment: Other: group exposed; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control	Other: Control; Not exposed group
Other: children with Prenatal enlarged nuchal transluce	Other: group exposed; Assessment by Brunet Lezine scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of developmental quotient below 70 compared to a group control	assessed by the Brunet Lezine test	Assessment at the age of 2 years + / - 45 days for each patient

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of the mean and distribution of developmental quotient between the two arms	assessed by the Brunet Lezine test	at the age of 2 years + / - 45 days
composite outcome measure : comparison of weight, height and head circumference between the two arms	assessed by measurement	at 3 months, 1 year and 2 years
The status deceased / living and the date and cause of death if applicable	nterview	any time after birth and before 2 years + / - 45 days
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	at the consultation at the age of 2 years + / - 45 days of the children

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Study Director: Rachel BUFFIN, Dr, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: August 12, 2014
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 22, 2014

Study Record Updates

• Last Update Posted (Estimate): August 22, 2014
• Last Update Submitted That Met QC Criteria: August 21, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: nuchal translucency, neurological developpment, anxiety, depression, prenatal diagnosis, normal karyotype
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 2007-491