Pulse Oximeter Screening in Congenital Heart Disease

• Conditions: Congenital Heart Disease

• Registration Number: NCT02731248
• Lead Sponsor: Dr. Sami Ulus Children's Hospital

Brief 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

Study Timeline

• Status Verified: 2016-04
• Study Start: 2016-04
• Study First Submitted: 2016-04-02
• Study First Submitted QC: 2016-04-02
• Last Update Submitted: 2016-04-02
• Study First Posted: 2016-04-07
• Last Update Posted: 2016-04-07
• Primary Completion: 2017-04
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50000

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pulse oximeter positivity	6 months	Congenital heart disease detection by pulse oximeter

Secondary Outcome Measures

Name	Time	Method
echocardiographic confirmation	12 months	echocardiographic confirmation of congenital heart disease

Trial Locations

Locations (6)

Dr Sami Ulus Children Hospital; 🇹🇷 Ankara, Turkey

Ataturk University Medical Faculty; 🇹🇷 Erzurum, Turkey

Bursa Sevket Yılmaz Training and Research Hospital; 🇹🇷 Bursa, Turkey

Mersin Maternity Hospital; 🇹🇷 Mersin, Turkey

Mugla Sıtkı Koçman University Medical Faculty; 🇹🇷 Mugla, Turkey

Urfa Maternity Hospital; 🇹🇷 Urfa, Turkey