Only Use of Masimo SET Reduced Severe Blindness and Corrective Laser Surgery

Masimo announced  that a new multi-center study published in the International Peer-Reviewed Academic Journal, Acta Paediatrica, shows that a change in clinical practice with the use of Masimo SET pulse oximetry technology led to a significant reduction of severe Retinopathy of Prematurity (ROP)—a devastating eye disease resulting in partial or complete blindness—in premature newborns. The study also confirmed that conventional pulse oximetry technology is not effective in reducing ROP, even when clinical practice is changed to reflect lowered oxygen saturation targets.¹

ROP is the second leading cause of blindness in childhood in the United States—affecting over 20% of premature babies. A major cause of ROP is the use of excess oxygen to treat respiratory problems in premature babies,²which stimulates abnormal vessel growth within the eye. Although the use of pulse oximetry is established as a standard-of-care technology for measuring oxygen saturation and appropriately titrating oxygen administration to prevent ROP, accuracy and reliability varies greatly by which pulse oximetry technology is used. Masimo SET pulse oximetry technology is clinically-proven to measure-through motion and low perfusion, leading to accurate and reliable monitoring of oxygen saturation in premature newborns. Although previous clinical studies have shown a reduction in the incidence of ROP in premature newborns when Masimo SET pulse oximetry is used in combination with appropriate titration of oxygen administration,^3,4this is the first published study showing a head-to-head comparison of Masimo SET vs. another "next generation" pulse oximetry.

In the current study, researchers examined the role that SpO2 technology plays in the prevention of ROP in 571 high-risk premature newborns (weighing less than 1,250 grams / 2.75 lbs) at two Emory University (Atlanta, GA) hospitals during two consecutive three-year periods (Periods 1 and 2) and an 18-month follow-up period (Period 3). During Period 1, Nellcor pulse oximeters were used in both centers and oxygen saturation targets were set at 92-100%. In Period 2, new practice guidelines for lower oxygen saturation targets of 88-93% for premature infants were implemented at both centers, but only one center switched to Masimo SET oximeters. In Period 3, the center previously using Nellcor oximeters switched to Masimo SET.

Study results showed that in Period 1, when both centers were using Nellcor, ROP rates were not different between centers. In period 2, when both centers implemented a practice change, the center switching to Masimo SET reduced ROP rates from 12% to 5% while the center using Nellcor did not reduce ROP rates at all, remaining at a 13% ROP rate. In period 3, the center previously using conventional pulse oximetry switched to Masimo SET and reduced ROP rates from 13% to 6%. Researchers concluded that the "reduction in the incidence of severe ROP and need for laser therapy was associated with the use of signal extraction pulse oximetry (Masimo SET)" and the study "findings lend further support to the significance of using improved saturation monitors in managing critically-ill infants."

According to lead researcher, Armando Castillo, MD, Neonatologist at Northeast Georgia Medical Center, "Our study findings show that Masimo SET is not only clinically beneficial, but uniquely impactful for reducing the incidence and prevalence of ROP in Extremely Low Birth Weight infants. As such, NICU clinicians wanting to use evidence-based strategies should seriously consider implementing Masimo SET."