Neonatal Pulse Oximetry Sensor Study

Completed · Not applicable

Conditions studied: Premature Birth

In brief

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.

Key facts

Study ID

NCT05250102

Run by

Medline Industries

People needed

23

Starts

2022-06-13

Expected to finish

2023-10-10

Last updated by the study team

2024-10-30

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• Eastern Carolina University — Greenville, North Carolina, United States

Full record on ClinicalTrials.gov

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