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临床试验/NCT02731248
NCT02731248Unknown不适用

Pulse Oximeter Screening for Critical Congenital Heart Disease in Newborns

Dr. Sami Ulus Children's Hospital6 个研究点 分布在 1 个国家目标入组 50,000 人开始时间: 2016年4月最近更新:
适应症

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

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

发起方
Dr. Sami Ulus Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilek Dilli

Assoc Prof

Dr. Sami Ulus Children's Hospital

研究点 (6)

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