Pediatric Pulse Oximeters are a fairly accurate way to screen newborns for critical congenital heart defects, a meta-analysis determined.
The blood oxygenation sensor detected such defects with 76.5% sensitivity and 99.9% specificity, which compares favorably with other methods of detection such as antenatal ultrasound and routine physical exam.
The false-positive rate was low at just 0.14% across the pooled results reported online in The Lancet.
Those findings suggest newborn pulse oximetry meets criteria for universal screening, the researchers concluded. It has already been adopted into the recommended uniform newborn screening panel in the United States, though other countries have yet to follow.
Pulse oximetry itself isn't the issue, as the Pediatric Pulse Oximeter devices are widely available, testing is noninvasive and easy, and the cost per screen is low. Guaranteeing follow-up after a positive screen will be the biggest barrier to adoption of screening. Many hospitals do not have access to pediatric echocardiography, which is needed for newborn babies with a positive screen not attributable to another cause.
Anecdotal reports from New Jersey, which became the first state to implement pulse oximetry into state-wide newborn screening in mid-2011, suggest that those issues haven't been overly problematic and point to at least two unexpected defects being found.
It is expected that the debate about whether pulse oximetry screening should be part of newborn screening or clinical care to continue until we have better ways to assess explicitly the economic and health outcomes of each approach.
The meta-analysis tackled one aspect of that uncertainty through pooling accuracy results from 13 eligible studies with a total of 229,421 asymptomatic newborn babies.
Pulse oximetry done within 24 hours of birth, which was the case in six of the studies, didn't impact sensitivity for screening (P=0.36).
But it did affect the false-positive rate, which was especially low when done more than 24 hours after birth at 0.05%, compared with 0.50% when done sooner after delivery (P=0.0017).
That low rate would be important in keeping down costs for assessing test-positive infants, the researchers pointed out. This finding should be balanced against the increasing tendency of many countries to discharge babies early (between 6 and 24 hours), and the risk of infants with serious disorders deteriorating before screening has been done.
The site where oxygen saturation was measured didn't appear to make a difference in sensitivity either, comparing results in the 60% of studies that used the foot alone versus those of the rest testing both the right hand and foot (P=0.22).
False-positive rates also did not differ significantly by probe positioning (P=0.66).
Most studies excluded newborns with antenatal suspicion of congenital heart defects, but those that included them had higher false-positive rates (P<0.0001) without much boost in sensitivity of pulse oximetry (P=0.18).
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