NCT02731248

Pulse Oximeter Screening in Congenital Heart Disease

Pulse Oximeter Screening for Critical Congenital Heart Disease in Newborns

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50,000 (estimated)
• Sponsor: Dr. Sami Ulus Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 5 Days
• Healthy volunteers: Accepted

Summary

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

Detailed description

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

Conditions

• Congenital Heart Disease

Interventions

Type	Name	Description
OTHER	Prospective screening study	Prospective screening study in newborns

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-04-01
• Completion: 2017-05-01
• First posted: 2016-04-07
• Last updated: 2016-04-07

Locations

6 sites across 1 country: Turkey (Türkiye)