N/A
Completed N=117
U-TruSignal SpO2 Testing in Neonates
Pulse Oximetry
Source: ClinicalTrials.gov NCT03383757 ↗
Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Accuracy Root Mean Square (ARMS) Per Data Pair — 2.57; 2.57 percentage of oxygen saturated hemoglobi
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 with human subjects will provide the needed clinical evidence for assessing the accuracy of the pulse oximeter as recommended by the FDA Guidance Document (Pulse Oximeters - Premarket Notification Submissions [50(k)s]: Guidance for Industry and Food and Drug Administration Staff.)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy Root Mean Square (ARMS) Per Data Pair |
2.57; 2.57 | — |
| SECONDARY Continuous SpO2 Measurements During Data Collection Interval |
38; 0; 40; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03383757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.