N/A
Completed N=23
Neonatal Pulse Oximetry Sensor Study
Source: ClinicalTrials.gov NCT05250102 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Bland-Altman Analysis for Nellcor Pulse Oximeter — .151; .434 percentage of difference in mean
Summary
To validate the SpO2 accuracy, bias, and precision of Medline's reprocessed pulse oximetry sensors as compared to SaO2 in arterial blood samples as assessed by CO-oximetry in neonates.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bland-Altman Analysis for Nellcor Pulse Oximeter |
.151; .434 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who are postnatal 28 days or younger (neonates)
- Subjects who are likely to receive one or more ABG measurements as part of their clinical SOC
- Subjects who weigh less than 5 Kg (weight range for thesensors)
Exclusion Criteria
- Subjects with current signs and symptoms of a clinically significant Patent Ductus Arteriosus (PDA) combined with a current or planned arterial line placement which will affect the validity of the co-oximetry measurement
- Subjects with physical malformation of hands, fingers, feet, or toes that would limit the ability to place sensors for this study
- Subjects judged by the Principal Investigator (PI) to be inappropriate for participation in this study
- Subjects for whom placing a pulse oximeter will cause dermatological issues (e.g. allergic to foam rubber or adhesive tape)
Data sourced from ClinicalTrials.gov (NCT05250102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.