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

NCT ID: NCT02223936

Last Updated: 2014-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2014-03-31

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.

Conditions

Neurological Development After Exposition to an Antenatal Nuchal Translucency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

children with Prenatal enlarged nuchal transluce

Group Type: OTHER

group exposed

Intervention Type: OTHER

Assessment by Brunet Lezine scale

Control

Group Type: OTHER

Control

Intervention Type: OTHER

Not exposed group

Interventions

group exposed

Assessment by Brunet Lezine scale

Intervention Type: OTHER

Control

Not exposed group

Intervention Type: OTHER

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.

• 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

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

• Maximum Eligible Age: 26 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel BUFFIN, Dr

Role: STUDY_DIRECTOR

Hospices Civils de Lyon

Other Identifiers

2007-491

Identifier Type: -

Identifier Source: org_study_id