Philips FAST SpO2 monitoring with Masimo neonatal, infant, and pediatric sensors
Official title: Philips FAST SpO2 Technology With Masimo Sensors for SpO2 Monitoring in the Neonatal, Infant, and Pediatric Populations
Run by Masimo Corporation · NCT07223177 · Data updated 2026-11-12
This project will test whether Philips FAST SpO2 technology works correctly with Masimo sensors to measure blood oxygen in newborns, infants, and children.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Years to 21 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Masimo Corporation Industry-sponsored |
| Locations | 2 sites (Modesto, California and 1 other locations) |
| Status | Recruiting |
| Started | December 17, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 13, 2026 |
| Trial ID | NCT07223177 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are neonates, infants, and pediatric patients under 22 years who fall within the indicated populations for the Philips FAST monitor and can tolerate standard sensor placement without exclusion criteria.
✕Probably not a fit
Patients with skin conditions at the sensor site, distinct localized pigmentary anomalies (e.g., vitiligo at the site), absence/deformity of limbs, severe edema, or who refuse removal of interfering nail polish/acrobatics are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional convenience-sample study will connect Masimo neonatal, infant, and pediatric sensors (RD SET and/or LNCS) to a Philips monitor running the FAST SpO2 algorithm to verify form, fit, and function. Data will be collected from indicated patient populations (neonates through age 21) across a range of skin pigmentations. Measurements will be taken simultaneously with an FDA-cleared pulse oximeter as a comparator to compare readings. The aim is to confirm reliable sensor performance and proper sensor fit in the intended pediatric populations.
Why it matters
Potential benefit: If successful, this could improve availability of compatible sensor-monitor pairings and help ensure accurate oxygen readings for babies and children using Masimo sensors with Philips monitors.
How similar studies have gone: Masimo sensors and pulse oximetry have been validated in prior studies, but the specific integration and verification of Masimo sensors with Philips' FAST algorithm is a focused compatibility check being performed here.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject falls within the indicated population for the Philips FAST SpO2 Monitor with the Masimo sensor. * Subject is less than 22 years of age (pediatric subject per US FDA definition). Exclusion Criteria: * Subject has a skin condition or deformity at the planned sensor application site, which would preclude sensor placement and measurements as standard of care (e.g., psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown). * Confounders of pulse oximetry per sensor direction for use (DFU). * Subject with distinct geographic variances in skin pigmentation (e.g., vitiligo), where the sensor is applied. * Subject has an absence or deformities of limbs or severe edema, which would interfere with sensor application or prevent the proper fit of the sensors. * Subject with nail polish or acrylic nails on the digits where sensor needs to be applied, who opts to not remove it. * Subject with known allergic reactions to adhesive tapes. * Subject is not suitable for the investigation at the discretion of the clinical research team.
Where it's running
-
Paradigm Clinical Research
Modesto, California, United States Recruiting -
Paradigm Clinical Research
San Diego, California, United States Recruiting
Study contacts
- Study coordinator: Chelsea Frank
- Email: clinicalresearchdept@masimo.com
- Phone: 949-297-7000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.