Largest Study on Newborns Highlights Device Accuracy
Masimo announced findings from a comprehensive study that demonstrates its SET pulse oximetry technology accurately measures blood oxygen levels in newborns across all skin tones. This landmark study, the largest of its kind, was unveiled at the Pediatric Academic Society meeting in Boston on April 27th.
The NeoPODS study was conducted by researchers from the University of California, Davis, and the University of Mississippi, Jackson. It evaluated 200 critically ill neonates and found less than 1% overall statistical bias, with no significant discrepancies due to skin pigmentation. The study included a diverse sample of newborns from various racial backgrounds.
Dr. Heather Siefkes, the study’s lead author, emphasised, “We found no evidence of clinically meaningful skin tone-related discrepancies, suggesting equitable monitoring performance for this device in this clinical setting.”
Study Methodology and Findings
The research involved newborns hospitalized in neonatal intensive care units with gestational ages as young as 26 weeks. Masimo RD SET Neo sensors were used to continuously monitor SpO2 levels, aiming to assess the mean bias between noninvasive SpO2 and invasive SaO2 measurements across different skin tones.
Results indicated a mean bias of -0.98% with no significant trend related to skin pigmentation. Only one instance of occult hypoxemia was recorded, which occurred in a patient classified with the lightest skin tone.
Dr. Siefkes presented the findings at 10 am EST, highlighting that the study’s rigorous methodology provided a high level of accuracy and reliability. The research was funded by the NIH and adds to the growing body of evidence supporting the efficacy of Masimo’s technology in diverse patient populations.
Daniel Cantillon, Chief Medical Officer at Masimo, remarked, “Once again, we’re highly encouraged to see Masimo’s RD SET technology demonstrate less than 1% overall bias without occult hypoxemic events among Black or Hispanic infants.”
These findings corroborate previous research, including the INSPIRE feasibility study, which showed that SET pulse oximetry performed accurately on critically ill adult medical ICU patients of all skin tones. The full INSPIRE study, involving approximately 500 adult patients, is expected to be published later this year.
Importantly, the study revealed that accurate detection of hypoxemia is especially crucial in NICU patients, as it influences many care pathway decisions. This aspect of the research underscores the significance of using reliable pulse oximetry in neonatal care.
The study’s results, presented alongside their online publication in the Journal of Pediatrics, add to existing evidence of Masimo SET’s strong performance under challenging real-world conditions. The findings were shared from the podium at the Pediatric Academic Society meeting held in Boston, MA.
