Status:
COMPLETED
Neonatal Pulse Oximetry Sensor Study
Lead Sponsor:
Medline Industries
Conditions:
Premature Birth
Eligibility:
All Genders
1-28 years
Phase:
NA
Brief 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.
Detailed Description
Pulse oximetry helps in measuring peripheral capillary oxygen saturation (SpO2) continuously and non-invasively, and provides an indirect measurement of arterial oxygenation (SaO2) based on the red an...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2023
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05250102
Start Date
June 13 2022
End Date
October 10 2023
Last Update
October 30 2024
Active Locations (2)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
Eastern Carolina University
Greenville, North Carolina, United States, 27858