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Pulse Oximeter Screening in Congenital Heart Disease (POX)

D

Dr. Sami Ulus Children's Hospital

Status

Unknown

Conditions

Congenital Heart Disease

Treatments

Other: Prospective screening study

Study type

Observational

Funder types

Other

Identifiers

NCT02731248
SamiUlusCH-CHD

Details and patient eligibility

About

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

Full 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

Enrollment

50,000 estimated patients

Sex

All

Ages

1 to 5 days old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

6

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Central trial contact

Dilek Dilli, Assoc Prof

Data sourced from clinicaltrials.gov

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