NCT04830241Unknown不适用
Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant-Analysis of Two Pharmacovigilance Databases
适应症
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- neonatal hypotonia
研究概览
简要总结
To better characterize the neonatal hypotonia associated with in utero exposure to antidepressants, so far limited to clinical cases, we will perform an observational retrospective pharmacovigilance study, using two databases. First, disproportionality analysis in Vigibase®, the World Health Organization global database, will be perform between antidepressant drugs and neonatal hypotonia . Second, narratives from the French National Pharmacovigilance Database will be extracted.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •neonatal hypotonia newborns cases associated with in utero exposure to antidepressant drugs
排除标准
- •Reports with maternal suicide, congenital malformation and hypotonia occurring only during breastfeeding
结局指标
主要结局
neonatal hypotonia
时间窗: Case reported in the World Health Organization (WHO) pharmacovigilance database to April 1st 2021
Identification and extractions of cases of neonatal hypotonia newborns following in utero exposure to antidepressant drugs
次要结局
未报告次要终点
研究者
研究点 (1)
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