The Impact of Implementing a Universal Newborn Screening for Critical Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pediatrix
- 入组人数
- 6,147
- 试验地点
- 1
- 主要终点
- True Positive Rate
研究概览
简要总结
The purpose of this study is to evaluate the impact of implementing a universal pulse oximeter screening as a way to detect critical congenital heart disease in otherwise well-appearing 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
- — 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documentation of informed consent and authorization.
- •Full term and late preterm newborns (EGA 35-44 weeks)
- •On room air
- •Neonates known to have a congenital heart defect at the time of screening, e.g., antenatal diagnosis or diagnosis within the first 24 hours after birth
- •Parents agree to follow-up contact post discharge
排除标准
- •On supplemental oxygen
- •Admitted to the Neonatal Intensive Care Unit
- •Parents do not agree to follow-up
- •Greater than 30 days of age
结局指标
主要结局
True Positive Rate
时间窗: One year follow-up
The numbers of subjects who have a positive pulse oximetry screening test and who in follow-up evaluation are found to have CCHD.
False Positive Rate
时间窗: One year follow-up
The numbers of subjects who have a positive pulse oximetry screening test and who in follow-up evaluation are found to have normal hearts.
False Negative Rate
时间窗: One year follow-up
The number of subjects who have a negative pulse oximetry screening test and who in follow-up evaluation are found to have heart defects.
True Negative Rate
时间窗: One year follow-up
The number of subjects who have a negative pulse oximetry screening test and who in follow-up evaluation are found to have normal hearts.
次要结局
未报告次要终点