Comparing pulse oximeters in newborns
Pulse Oximetry Performance Comparison in Newborns
Medtronic - MITG · NCT06637917
This study is testing two different pulse oximeters to see which one gives more accurate readings of heart rate and oxygen levels in newborns right after birth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 29 Weeks and up |
| Sex | All |
| Sponsor | Medtronic - MITG (industry) |
| Locations | 3 sites (Los Angeles, California and 2 other locations) |
| Trial ID | NCT06637917 on ClinicalTrials.gov |
What this trial studies
This observational study aims to directly compare the performance of two different pulse oximeters in measuring pulse rate and oxygen saturation in newborns. The study will involve the use of the OxySoftN™ Neonatal-Adult SpO2 Sensor with the N600X Nellcor™ Patient Monitoring System and the LNCS® NEO SpO2 Sensor with the RAD-97™ Pulse CO-Oximeter. Newborns who meet the eligibility criteria will be monitored in the delivery room to assess the effectiveness of these devices in real-time. The goal is to determine which device provides more accurate readings for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns who are at least 29 weeks gestational age and can accommodate multiple sensors.
Not a fit: Patients with existing health conditions that may interfere with accurate oximetry measurements, such as major congenital anomalies or limb anomalies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of oxygen saturation monitoring in newborns, leading to better clinical outcomes.
How similar studies have performed: While this study focuses on a specific comparison of pulse oximeters, similar studies have shown varying degrees of success in improving monitoring techniques in neonatal care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Parent or legal guardian is willing and able to provide informed consent prior to any study procedures being performed. * Subject is expected to be able to participate for the duration of the evaluation in the delivery room. In most instances, the length of the study will not exceed the anticipated duration of ECG monitoring. * Subject is ≥ 29 weeks gestational age. * Subject can accommodate multiple sensors. Exclusion Criteria: * Subjects that have an existing health condition, in which the investigator determines that safe or accurate oximetry measures may not be obtained at the areas where the PO sensor could be placed. For example, major congenital anomalies, limb anomalies or anyone with abrasions or surface lesions on the contact areas would be excluded. * Any subject whose treatment or condition would be compromised if they were to participate in this study and any patient whose use of a pulse oximeter and sensor would present a potential for serious risk to health, safety, or welfare. * Currently participating in any other study expected to confound study results in the opinion of the investigator.
Where this trial is running
Los Angeles, California and 2 other locations
- Cedars-Sinai — Los Angeles, California, United States (RECRUITING)
- Washington University in St. Louis — Saint Louis, Missouri, United States (RECRUITING)
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (RECRUITING)
Study contacts
- Study coordinator: Anna Klochak
- Email: anna.l.klochak@medtronic.com
- Phone: 3032633702
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Newborn, Birth, Preterm