N/A
N=23
Neonatal Pulse Oximetry Sensor Study
Premature Birth
Bottom Line
View on ClinicalTrials.gov: NCT05250102 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Bland-Altman Analysis for Nellcor Pulse Oximeter — .151; .434 percentage of difference in mean
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pulse oximeter sensors (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Medline Industries
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bland-Altman Analysis for Nellcor Pulse Oximeter |
.151; .434 | — |
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.
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.