The Effectiveness of Cardio-auscultation and Pulse Oximetry Combined Screening of Congenital Heart Disease in Newborns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40,000
- 试验地点
- 1
- 主要终点
- Severe congenital heart disease
研究概览
简要总结
The investigators conducted this retrospective study in a large single center with an annual birth of more than 20,000 newborns, from January 1, 2018 to December 31, 2019, to confirm the applicability and accuracy of pulse oximetry (POX) combined cardio-auscultation to screen congenital heart disease for neonates.
详细描述
All consecutive newborn babies were eligible, irrespective of gestational age, NICU admission, symptom presence or prenatal diagnosis.
This study was approved by institutional ethical review board of Linyi Maternal and Child Healthcare Hospital. Spoken informed consent was obtained from the participating babies' parents.
Physicians from departments of neonatal medicine and developmental medicine undertake auscultation screening. When abnormal murmur occurred, an echocardiography would be requested to confirm if the newborn has CHD or not.
Physicians from obstetrics department and nursing staff from neonatal department undertake POX measurement. If a positive POX occurred, an echocardiography would be requested to confirm if the newborn has CHD or not.
Physicians from department of ultrasonography undertake echocardiography confirmation for newborns deemed positive by auscultation or POX.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Hours 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive newborn babies delivered in the study center were eligible, irrespective of gestational age, NICU admission, symptom presence or prenatal diagnosis.
排除标准
- 未提供
结局指标
主要结局
Severe congenital heart disease
时间窗: The first 24 hours after birth.
Patients who present as severely ill in the newborn period or early infancy, including those with cyanotic heart disease and acyanotic lesions like AVSD, large VSD, large PDA, critical or severe AS, severe PS, critical coarc.
次要结局
未报告次要终点