Diagnostic accuracy of pulse oximetry screening for critical congenital heart defects

To determine the diagnostic accuracy of pulse oximetry as a screening method for the detection of critical congenital heart defects in asymptomatic newborn infants. Diagnostic accuracy is described by the proportion of asymptomatic newborn infants with CCHD detected by a positive pulse oximetry result (sensitivity), and the proportion of asymptomatic newborn infants with a negative pulse oximetry result who did not have CCHD (specificity).

To assess potential sources of heterogeneity including:

  • study design: retrospective vs prospective design, consecutive vs non consecutive series
  • timing of testing: < 24 hours vs ≥ 24 hours after birth
  • site of testing: right hand and foot (pre-ductal and post-ductal) vs foot only (post-ductal)
  • oxygen saturation: functional vs fractional
  • characteristics of the population: antenatal screening.

This is a protocol.