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

Civil Hospices of Lyon

Status

Completed

Conditions

Neurological Development After Exposition to an Antenatal Nuchal Translucency

Treatments

Other: Control

Other: group exposed

Study type

Interventional

Funder types

Other

Identifiers

NCT02223936

2007-491

Details and patient eligibility

About

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.

Enrollment

500 patients

Sex

All

Ages

Under 26 months old

Volunteers

Accepts 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