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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| children with Prenatal enlarged nuchal transluce | Other |
| |
| Control | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| group exposed | Other | Assessment by Brunet Lezine scale |
| |
| 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 |
| 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 |
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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
Exclusion Criteria:
Multiple Pregnancy
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
Weight:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Rachel BUFFIN, Dr | Hospices Civils de Lyon | Study Director |
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| Control |
| Other |
Not exposed group |
|
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 |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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