NCT02223936已完成不适用
Follow up of Neurologic Development of Children Who Presented at the First Trimester of Pregnancy an Isolated Nuchal Anomaly With Normal Karyotype
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 主要终点
- Incidence of developmental quotient below 70 compared to a group control
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- — 至 26 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •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
结局指标
主要结局
Incidence of developmental quotient below 70 compared to a group control
时间窗: Assessment at the age of 2 years + / - 45 days for each patient
assessed by the Brunet Lezine test
次要结局
- composite outcome measure : comparison of weight, height and head circumference between the two arms(at 3 months, 1 year and 2 years)
- comparison of the mean and distribution of developmental quotient between the two arms(at the age of 2 years + / - 45 days)
- 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)
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