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Breaking Multi-Center Study: Masimo SET Pulse Oximetry Technology,Shown to Significantly Lower Instances of Severe Retinopathy of,Prematurity in Extremely Low Birth Weight Infants

fferent Health Care Centers and isolate the difference made by the pulse oximetry technology. The clinical changes included increased education and commitment of bedside care givers along with guidelines to decrease hyperoxemic periods and wide changes in oxygenation. Nellcor N395 pulse oximeters, with claims of accuracy during motion and low perfusion, were used in both Centers prior to the clinical practice changes, while after these changes Center #1 switched to Masimo SET pulse oximetry and Center #2 kept the Nellcor technology.

In Center #1, pre-change rates from 2000-2002 for ROP (III and IV) and laser treatments were 11.1% and 4% respectively, decreasing to 6% and 2.5% in 2003-2004 after the change in clinical practice and switch to Masimo SET -- representing a 40% relative risk reduction in severe ROP. For the same time periods in Center #2, ROP (III and IV) and laser treatment rates remained unchanged at 13% and 5% respectively after changing clinical practice and maintaining use of Nellcor N395 technology, leading researchers to state that the results were "significantly more favorable" for the center that switched to Masimo technology.

"In a large group of examined inborn infants <1,250 grams treated by the same neonatologists, MDs and NNPs using the same clinical guideline to decrease hyperoxemia and wide changes in oxygenation, the relative risk rate of severe ROP and laser therapy are associated with the SpO2 technology utilized," the researchers concluded. "This further supports the significance of adequate SpO2 monitors in managing critically ill infants."

Joe E. Kiani, Chairman and CEO of Masimo stated; "In 2002, a group of researchers at Cedars Sinai led by Dr. Sola published a ground-breaking study, which showed that a new oxygen titration protocol, including the monitoring of the neonates' arterial blood oxygen saturation with Masimo SET pulse oximetry, could dramatically reduce ROP. But some observers questioned how critical
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