Skip to content

Pulse Oximeter Screening in Congenital Heart Disease

Pulse Oximeter Screening for Critical Congenital Heart Disease in Newborns

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02731248
Acronym
POX
Enrollment
50000
Registered
2016-04-07
Start date
2016-04-30
Completion date
2017-05-31
Last updated
2016-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

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

Interventions

OTHERProspective screening study

Prospective screening study in newborns

Sponsors

Dr. Sami Ulus Children's Hospital
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 5 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
pulse oximeter positivity6 monthsCongenital heart disease detection by pulse oximeter

Secondary

MeasureTime frameDescription
echocardiographic confirmation12 monthsechocardiographic confirmation of congenital heart disease

Countries

Turkey (Türkiye)

Contacts

Primary ContactDilek Dilli, Assoc Prof
+905422368250

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026