Outcome of Infants With Prenatal Corpus Callosum Agenesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- WPPSI-III (wechsler preschool and primary scale of intelligence) :evaluation of intellectual quotient ( questionnaire)
研究概览
简要总结
The purpose of this study is to assess the neurological development at three years of age of children born after prenatal diagnosis of "isolated" agenesis of the corpus callosum.
详细描述
Agenesis of the corpus callosum is the most frequent brain malformation. This anomaly may be diagnosed by ultrasound screening. In half of these prenatal cases, the anomaly seems to be isolated. In this setting, there are no prospective data concerning the development of these children, preventing any clear information to be delivered to parents. Prenatal diagnostic centers therefore face extremely variable rates of termination of pregnancies (TOP), which can reach up to 80%.
This is a multicentric prospective interventional study whose primary objective is to assess the neurological development at three years of age of children born after prenatal diagnosis of "isolated" agenesis of the corpus callosum.
Evaluation at three years will include Intellectual Quotient (IQ) quantification using the WPPSI-III, 3rd edition of Wechsler Preschool and Primary Scale of Intelligence and evaluation of intra-hemispheric coordination using the Vineland adaptative behaviour scale.
Secondary objectives will include:
- Circumstances leading to the prenatal diagnosis of agenesis of the corpus callosum
- Causes leading to termination of pregnancies
- Determination of criteria allowing to confirm that agenesis of the corpus callosum is isolated (family history, imagery, genetics)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pregnant women from 28 weeks of gestation
- •Complete agenesis of the corpus callosum
- •Partial agenesis of the corpus callosum
- •Abnormal corpus callosum (size, anatomy) As diagnosed by an expert ultrasound fetal brain examination.
排除标准
- •age < 18 years old
- •women who do not understand french
- •women not covered by the French social security system
- •refusal to participate
结局指标
主要结局
WPPSI-III (wechsler preschool and primary scale of intelligence) :evaluation of intellectual quotient ( questionnaire)
时间窗: 3 years
Neurodevelopment outcome
次要结局
- CBCL: Child Behavior Checklist (behaviour) : self administered questionnaire(3 years)
- Vineland adaptative behaviour scales (motricity capacity) : questionnaire(3 years)
- Nepsy : developmental neuropsychological assessment (capacity of coordination)(3 years)
- Cerebral abnormalities(up to 3 years)