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U.S. Health & Human Services Makes Critical Congenital Heart Defect Screening Using Motion-Tolerant Pulse Oximetry a Nationwide Newborn Screening Standard
Date:9/23/2011

d Kidney Disease at Children's National Medical Center in Washington, D.C., stated, "The excellent results that we can now achieve in correcting critical congenital heart defects make timely diagnosis even more important.  Adding pulse oximetry screening as an important adjunct to fetal ultrasound and newborn physical examination will help to ensure that no baby is missed.  This is a major win for babies born with congenital heart diseases, as well as the families and providers who care for them."

Latest Published Study to Show Masimo SET Improves Early CHD Detection in Newborns

In the current Lancet-published study, researchers screened 20,055 asymptomatic newborn babies (gestation >34 weeks) at six UK maternity units using Masimo SET pulse oximetry before discharge. Newborns with oxygen saturation (SpO2) of less than 95% in either limb or a difference of more than 2% between limbs were considered positive for CHD and underwent echocardiography.  Results showed that 53 babies had major CHDs (24 critical)—a prevalence of 2.6 per 1,000 live births.  Masimo SET pulse oximetry achieved sensitivity of 75% (95% CI 53.29–90.23) for critical CHDs (causing death or requiring invasive intervention before 28 days) and 49% (95% CI 35.06–63.16) for all major CHDs (causing death or requiring invasive intervention within 12 months of age.)(1)

Findings also showed that Masimo SET pulse oximetry helped clinicians increase CHD detection by 34% versus antenatal ultrasonography alone (from 35 cases to 53 cases). In addition, out of the 0.8% false-positive results (169), 27% had other problems that required medical intervention (6 were significant but not major congenital heart defects and 40 were other illnesses like respiratory disorders and infections)—showing that the sensitivity of Masimo SET enabled identification of other life-threatening newborn conditions that likely would have otherwis
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