Timing of Closure of Patent Foramen Ovale and Patent Ductus Arteriosus Following Birth
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Patent Foramen Ovale size using 2 echocardiography positions, shunt direction and distance of septum primum to Superior Vena Cava
研究概览
简要总结
It is known that the foramen ovale closes in most infants during the first 6 months of life, however, most of the important papers in the field concentrated on observing infants with murmurs and following those with patent foramen ovale by echocardiography until 6-24 months. The purpose of this study is to observe the natural profile of closure of the foramen ovale and ductus arteriosus for the first 36 hours after birth. This understanding may help to avoid unnecessary treatment and exams for newborns with findings that are natural for their stage of development.
详细描述
We will observe the patency and size of foramen ovale five times within the first 36 hours of life. We will also describe the anatomy of the foramen ovale and the septum primum during this time. The direction of flow across the foramen ovale will also be observed. Other cardiac lesions will be checked for as well. We will measure the change in size of the pulmonary arteries and the closure of the ductus arteriosus.
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
- 30 Minutes 至 4 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •any baby born in term and with normal delivery
排除标准
- •sick newborns in need of neonatal intensive care for any medical reason.
- •newborns with congenital heart disease except for small, muscular ventricular septal defects
结局指标
主要结局
Patent Foramen Ovale size using 2 echocardiography positions, shunt direction and distance of septum primum to Superior Vena Cava
时间窗: 2-3 hours after birth, 5-6 hours, 7-8 hours, 12-13 hours and 36 hours
次要结局
- Patent Ductus Arteriosus size, shunt direction and the size of the Left Pulmonary Artery, the Right Pulmonary Artery and the Pulmonary Annulus(2-3 hours after birth, 5-6 hours, 7-8 hours, 12-13 hours, 36 hours)