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

Hospices Civils de Lyon0 sites500 target enrollmentFebruary 2009

ConditionsNeurological Development After Exposition to an Antenatal Nuchal Translucency

Overview

Phase: N/A
Intervention: Not specified
Conditions: Neurological Development After Exposition to an Antenatal Nuchal Translucency
Sponsor: Hospices Civils de Lyon
Enrollment: 500
Primary Endpoint: Incidence of developmental quotient below 70 compared to a group control
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

March 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospices Civils de Lyon

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

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

assessed by the Brunet Lezine test

Secondary Outcomes

composite outcome measure : comparison of weight, height and head circumference between the two arms(at 3 months, 1 year and 2 years)
comparison of the mean and distribution of developmental quotient between the two arms(at the age of 2 years + / - 45 days)
The status deceased / living and the date and cause of death if applicable(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(at the consultation at the age of 2 years + / - 45 days of the children)