Pulse Oximeter Screening for Critical Congenital Heart Disease in Newborns
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50,000
- 试验地点
- 6
- 主要终点
- pulse oximeter positivity
研究概览
简要总结
Pulse oximetry screening of newborn infants increases early detection of critical congenital heart disease and minimises the risk of circulatory collapse before surgery. This study provides an update on the implementation of pulse oximetry screening in Turkey
详细描述
The early detection of life-threatening, critical congenital heart defects in newborn babies still presents an important clinical challenge. Most defects are amenable to intervention but timely diagnosis (ie, before presentation with cardiovascular collapse or death) is crucial. In high-income countries, examination and, increasingly, antenatal ultrasound have formed the basis of screening, but test accuracy of these procedures is variable and many babies with critical congenital heart defects are discharged before diagnosis. Pulse oximetry screening of newborn infants increases early detection of critical congenital heart disease and minimises the risk of circulatory collapse before surgery. This study provides an update on the implementation of pulse oximetry screening in Turkey
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 5 Days(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Babies within the first 24-72 hours followed up in well baby nurseries
- •Babies prior to discharge, if discharged before 24 hours of age,
- •Babies ≤5 days and still followed up in well baby nurseries
- •Babies born ≥35 gestational weeks
排除标准
- •Babies within the first 12 hours of life
- •Babies >5 days of life
- •Babies with a gestational age of >35 weeks
- •Babies with major congenital anomaly except congenial heart disease
- •Babies who had a prenatal diagnosis of congenital heart disease
结局指标
主要结局
pulse oximeter positivity
时间窗: 6 months
Congenital heart disease detection by pulse oximeter
次要结局
- echocardiographic confirmation(12 months)
研究者
Dilek Dilli
Assoc Prof
Dr. Sami Ulus Children's Hospital
