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

NCT02223936 | Completed

• 1 other identifier: 2007-491
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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

Keywords

nuchal translucency, neurological developpment, anxiety, depression, prenatal diagnosis, normal karyotype

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• comparison of the mean and distribution of developmental quotient between the two arms

  at the age of 2 years + / - 45 days

• composite outcome measure : comparison of weight, height and head circumference between the two arms

  at 3 months, 1 year and 2 years

• 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

Study Arms (2)

children with Prenatal enlarged nuchal transluce

OTHER

Other: group exposed

Control

OTHER

Other: Control

Interventions

group exposed OTHER

Assessment by Brunet Lezine scale

children with Prenatal enlarged nuchal transluce

Control OTHER

Not exposed group

Control

Eligibility Criteria

• Age: Up to 26 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Rachel BUFFIN, Dr

  Hospices Civils de Lyon

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 22, 2014
• Study Start: February 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2014
• Last Updated: August 22, 2014

Record last verified: 2014-07