Courbes Normatives De Volumes Cérébraux Issues D'IRM Fœtales Multicentriques
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,423
- 试验地点
- 1
- 主要终点
- Determine normative brain volume curves
研究概览
简要总结
Fetal brain MRI is an essential diagnostic tool to inform parents about the prognosis of abnormalities detected on routine ultrasound. Recent work has shown that brain MRI measurements at the antenatal stage are predictive of the child's postnatal development. However, this work remains limited to basic research, in part because of the lack of normative curves of brain tissue volume evolution from fetal MRI acquired in clinical routine. This project aims to fill this gap. For this purpose, the project will exploit fetal MRI scans acquired in 4 French hospitals (Marseille, Nice, Montpellier and Paris): MRI scans without abnormalities will be centralized for analysis, and families who have undergone these scans will be contacted to evaluate the development of their children after birth. Normative curves will be established by applying a set of treatments developed by the laboratory in Marseille collaborating in the project. Ultimately, these curves will help to clarify the diagnosis of fetuses by providing a quantitative characterization of the normality of brain measurements.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child who has had, more than 3 years ago, a cerebral MRI during the fetal period in one of the 4 partner centers
排除标准
- •Child suffering from a commissural malformation (anomaly of the corpus callosum)
- •Child with a genetic syndrome and/or chromosomal abnormality and/or deleterious mutation
- •Child with syndromic extra-cerebral malformations (including cardiac malformations)
- •Child with intrauterine growth restriction reported in the obstetrical record
- •Child with maternal-fetal infection (TORCH, parvovirus or other) confirmed by amniotic fluid test or neonatal urine test
- •Multiple pregnancy
- •Mother with diabetes treated during pregnancy (including gestational diabetes, if treated)
- •Mother with antiepileptic medication during pregnancy
- •Alcohol or drug use
- •Presence of a sustentorial arachnoid cyst
- •Presence of an arachnoid cyst with mass effect
- •Objection from parental authority holders to participate in the study
结局指标
主要结局
Determine normative brain volume curves
时间窗: Through study completion, an average of 3 year
Curves calculated from fetal brain MRIs in fetuses between 20 and 37 weeks of amenorrhea with normal postnatal neurological development
次要结局
- Statistically compare the normative curves obtained with standard articles in the literature.(Through study completion, an average of 3 year)
- Sensitivity study: Possible influence of the scanner type on the estimated normative curves.(Through study completion, an average of 3 year)