Status:
COMPLETED
Follow up of Neurologic Development of Children Who Presented at the First Trimester of Pregnancy an Isolated Nuchal Anomaly With Normal Karyotype
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Neurological Development After Exposition to an Antenatal Nuchal Translucency
Eligibility:
All Genders
Up to 26 years
Phase:
NA
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 o...
Eligibility Criteria
Inclusion
- \-
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT02223936
Start Date
February 1 2009
End Date
March 1 2014
Last Update
August 22 2014
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