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Completed

NCT Number: NCT02223936

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

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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Key information

Age range

Up to 26 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

Treatment and study plan

group exposed

Other

Assessment by Brunet Lezine scale

Control

Other

Not exposed group

Primary outcomes

  1. 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

  1. comparison of the mean and distribution of developmental quotient between the two arms

    Time frame: at the age of 2 years + / - 45 days

    assessed by the Brunet Lezine test

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

    Time frame: at 3 months, 1 year and 2 years

    assessed by measurement

  3. The status deceased / living and the date and cause of death if applicable

    Time frame: any time after birth and before 2 years + / - 45 days

    nterview

  4. study differences in score post-traumatic stress, anxiety and depression between parents of the two arms

    Time frame: at the consultation at the age of 2 years + / - 45 days of the children

    assessment of the questionnaire of posttraumatic stress and HAD scale by the parents during the consultation of the two-year child

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: EDEN

Important dates

Study start
2009
Primary completion
2011
Study completion
2014
First posted
Aug 22, 2014
Registry last updated
Aug 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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