NCT05231447尚未招募不适用
Registry of Congenital Anomalies in Nouvelle-Aquitaine, France
University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 9,000 人开始时间: 2022年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 9,000
- 试验地点
- 1
- 主要终点
- Number of congenital anomalies
研究概览
简要总结
Regional population-based registry for the epidemiological surveillance of congenital anomalies
详细描述
By systematically collecting data on congenital anomalies, the registry aims to :
- provide essential epidemiological information on congenital anomalies in South West of France
- Promote etiological research concerning congenital anomalies, particularly with regard to environmental risk factors (systematic questionnaire) and other teratogenic agents (drugs)
- act as an information and resource center for the population, health professionals and managers regarding clusters or exposures or risk factors of concern.
- evaluate the effectiveness of primary prevention
- assess the impact of developments in prenatal screening
- study the fate of children with congenital anomalies, particularly in terms of neurodevelopment, through the creation of cohorts.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Minute 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children or Fetuses:
- •Born alive or stillborn or fetal death in utero or medical termination of pregnancy
- •Of mothers domiciled in New Aquitaine at the time of delivery
- •And presenting a congenital or chromosomal anomaly defined according to the EUROCAT network, diagnosed antenatally or postnatally up to one year of life.
- •Of which the non-opposition of both holders or of the only holder of parental authority has been given
- •Whose mother and/or father is affiliated or beneficiary of a social security system.
排除标准
- •Refusal of at least one of the holders of parental authority
结局指标
主要结局
Number of congenital anomalies
时间窗: 1 year-old
次要结局
- Measure of the incidence of congenital anomalies in south west region of France(1 year-old)
- Identification of environmental factors associated with congenital anomalies(1 year-old)
研究者
研究点 (1)
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