Table 5.
Summary of four large randomized trials on the use of pulse-oximetry for detection of CCHD.
| COUNTRY | GERMANY27 | NORWAY28s | SWEDEN26 | UK29 |
|---|---|---|---|---|
| Total infants | 41,445 | 50,008 | 39,821 | 20,055 |
| Study period | 2006–2008 | 2005–2006 | 2004–2007 | 2008–2009 |
| Age at screening | 24–72 hrs | 1–21 hrs | 1–406 hrs | Before discharge |
| Pulse oximetry site | Postductal | Postductal | Pre and postductal | Pre and postductal |
| Oxygen saturation cutoff | ≥96% | ≥95% | ≥95% | ≥95% |
| Pre – post ductal oxygen saturation difference | Not applicable | Not applicable | >3% | >2% |
| Number of retest | 1, after 1 hr | 1, after 2–3 hr | 2, 1 hr apart | 1, after 1–2 hr |
| Screening staff | Routine care providers | Routine care providers | Routine care providers | Routine care providers |
| Equipment | variable | Standardized | Standardized | Standardized |
| Sensitivity | 77.8 | 77.1 | 62.07 | 75 |
| Specificity | 99.9 | 99.4 | 99.82 | 99.12 |
| Positive predictive value | 25.9 | 8.3 | 20.69 | 9.23 |
| Negative predictive value | 99.99 | 99.98 | 99.97 | 99.97 |
| False positive rate | 0.10 | 0.6 | 0.17 | 0.8 |