A Study of Agreement Between Oxygen Saturation Measured by Two Probes in Infants on the Neonatal Unit

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

July 15, 2021

Primary Completion Date

January 11, 2023

Study Completion Date

January 14, 2023

Conditions
Neonatal Disease
Interventions
DEVICE

Oxygen saturation probe Mindray 520 N and Mindray 521 N

"Two oxygen saturation probes will be used in this study:~Mindray 520 N is a disposable oxygen saturation sensor for neonates and adults. It is a disposable, single-use sensor that is wrapped around the infant's arm or foot. Its ends stick together giving a firm, close contact with the skin.~Mindray 521 N is another disposable oxygen saturation sensor for neonates and adults that is used on the neonatal unit in routine practice. As Mindray 520 N and 521 N are CE marked and used within their intended purposes we do not require a letter of no objection from the MHRA for that usage. The Mindray probes will be used without modification and there are no safety issues to the patient. Therefore, a letter of no objection from the MHRA is not required and this is not a medical device study under the Medical Devices Directive."

Trial Locations (1)

DE3 0ED

University Hospitals of Derby and Burton, Derby

All Listed Sponsors
collaborator

University Hospitals of Derby and Burton NHS Foundation Trust

OTHER

lead

University of Nottingham

OTHER