Pulse Oximeter Screening for Critical Congenital Heart Disease in Newborns
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50,000
- Locations
- 6
- Primary Endpoint
- pulse oximeter positivity
Study Overview
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 Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Day to 5 Days (Child)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
pulse oximeter positivity
Time Frame: 6 months
Congenital heart disease detection by pulse oximeter
Secondary Outcomes
- echocardiographic confirmation(12 months)
Investigators
Dilek Dilli
Assoc Prof
Dr. Sami Ulus Children's Hospital