Status:
WITHDRAWN
SpO2 Accuracy In Vivo Testing for Neonates & Infants
Lead Sponsor:
Medline Industries
Collaborating Sponsors:
Clinimark, LLC
Conditions:
Pulse Oximetry
Eligibility:
All Genders
Up to 28 years
Phase:
NA
Brief Summary
The purpose of this clinical study is to validate the oxygen saturation (SpO2) accuracy of various pulse oximetry systems and sensors (new designs and/or reprocessed) during non-motion conditions as c...
Detailed Description
FDA Guidance for pulse oximeters (March 4, 2013), section 4.1.2, In vivo testing for SpO2 accuracy for neonates, calls for the devices to be first tested in adults during hypoxia tests with arterial s...
Eligibility Criteria
Inclusion
- Neonates/Infants up to 28 days old
- Neonates/Infants less than 5kg.
- And one of the following:
- Without PDA With a PDA with R-L shunting that will be repaired before arterial samples are taken
Exclusion
- Physical malformation of feet or toes or other sensor sites which would limit the ability to place the sensors for the study.
- Neonates/Infants older than 28 days old.
- Neonates/Infants outside the weight range for the sensor (Greater than 5kg.)
- Neonates/Infants with unrepaired PDA. with PDA with R-L shunting
- Subjects who are undergoing bilirubin light therapy while samples are being obtained.
Key Trial Info
Start Date :
March 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03843489
Start Date
March 19 2019
End Date
September 20 2021
Last Update
August 28 2024
Active Locations (1)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045