Copenhagen Baby Heart
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25,000
- 主要终点
- Prevalence of congenital heart defects
研究概览
简要总结
Copenhagen Baby Heart is an observational, cohort study of >30.000 children born in the Copenhagen area 2016-2018.
Newborns are examined with echocardiography, electrocardiogram, measurements of oxygen saturation and analyses of umbilical cord blood.
The main objectives of the baseline assessments in Copenhagen Baby Heart are to assess the prevalence of congenital and inherited heart disease unrecognized prenatally, to assess the yield of routine echocardiography shortly after birth and to establish reference values for echocardiography in Danish neonates.
Prospective follow-up of the birth cohort is planned with the purpose to assess the life-long development of cardiovascular disease as well as other conditions and to study associations between both pre- and postnatal exposure and disease, including life style, environmental and genetic factors.
详细描述
Copenhagen Baby Heart is an observational, cohort study of >30.000 children born in the Copenhagen area 2016-2018.
Purpose
- To assess the prevalence of congenital and inherited heart disease not detected prenatally, e.g. bicuspid aortic valve.
- To assess the diagnostic and clinical yield of routine echocardiography in neonates.
- To establish reference values for echocardiography and ECG for Danish neonates.
- To establish reference values for routine biochemical analyses in umbilical cord blood.
- To assess the prevalence of familial hypercholesterolemia in Danish newborns.
- To assess the life-long development of cardiovascular disease as well as other conditions and to study associations between both pre- and postnatal exposure and disease, including life style, environmental and genetic factors.
Methods Approximately 18.000 children are born yearly in the Copenhagen area. From 1. April 2016 - 1. April 2018 the parents of all newborns will be offered enrollment in the research project when attending a routine prenatal ultrasound.
Investigators plan to enroll >30.000 newborns.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Weeks 至 2 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born at one of three hospitals in the Copenhagen area
排除标准
- •Failure of providing consent (parents)
结局指标
主要结局
Prevalence of congenital heart defects
时间窗: 2 years
次要结局
未报告次要终点
研究者
Henning Bundgaard
Professor
Rigshospitalet, Denmark