Status:
COMPLETED
U-TruSignal SpO2 Testing in Neonates
Lead Sponsor:
GE Healthcare
Conditions:
Pulse Oximetry
Eligibility:
All Genders
Up to 29 years
Phase:
NA
Brief Summary
The purpose of the study is to demonstrate proper function of the U-TruSignal device via clinical performance testing in a neonatal human subject population under standard clinical conditions. A study...
Detailed Description
The purpose of this study is to collect blood samples from neonates under normal clinical conditions to ensure proper function (clinical performance) with the U-TruSignal device. The study will inclu...
Eligibility Criteria
Inclusion
- Parents or legally authorized representative (LAR) can understand and provide written informed consent; AND
- Subjects are \< 29 days old, and requiring arterial blood samples per the site's standard of care.
Exclusion
- Neonates with injuries, deformities or abnormalities may prevent proper application of the sensor;
- Neonates with inadequate heart pump function affecting blood circulation caused by identified cardiac or cardiovascular conditions such as patent ductus arteriosus, persistent pulmonary hypertension, septal defects, or congenital heart disease;
- Neonates with mean arterial blood pressure \< 20mmHg;
- Neonates with congenital diaphragmatic hernia; OR
- Neonates under High frequency ventilation therapy.
Key Trial Info
Start Date :
September 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT03383757
Start Date
September 14 2017
End Date
November 1 2019
Last Update
December 4 2020
Active Locations (2)
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1
Tampere University Hospital (TAYS)
Tampere, Finland, 33520
2
NH Narayana Multispecialty Hospital, Unit of Narayana Health, Mazumdar Shaw Medical Center
Bangalore, India, 560099