Owlet Pulse Oximeter for Newborns

Recruiting at 1 trial location

Overseen By Alisa L Niksch, M.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Owlet Baby Care, Inc.

Disqualifiers: Underdeveloped skin, Limb deformities, ECMO, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 48 hours

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The sponsor of this study, Owlet Baby Care, Inc., is comparing the accuracy of their pulse oximeter Sensor with the measurements of oxygen levels in newborns who are already being monitored with arterial blood samples. A minimum of 20, but up to 100 participants will be enrolled in a hospital environment and need to weigh 1500 grams or more. The purpose of the testing is to gather information on pulse oximeter readings taken by the Owlet OSS 3.0 Sensor and compare the readings to blood gas samples drawn by the medical staff. This will determine if the Owlet Sensor is accurate in newborns up to an age of 28 days after actual or expected delivery date. The Owlet OSS 3.0 is the Sensor component within the Owlet Dream Sock, an over the counter, noninvasive pulse oximeter which is currently FDA cleared in infants 1-18 months and between 6 and 30lbs, meant to be used in the home environment. The Owlet Sock is a fabric wrap that secures the Sensor to a baby's foot. The Sensor estimates the baby's SpO2, pulse rate, and measures movement level, and transmits the wearer's readings to the paired Base Station via low energy BlueTooth energy.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the Owlet OSS 3.0 Sensor treatment for newborns?

The Owlet Smart Sock (OSS) technology has been used to monitor heart rate and oxygen levels in a large group of newborns, with 94% of parents reporting better sleep quality, suggesting that the device is well-received and provides peace of mind. Additionally, studies comparing the wireless Owlet Smart Sock 3 to traditional wired devices in infants show its potential for effective monitoring. ^{1 2 3 4 5}

Is the Owlet Pulse Oximeter safe for newborns?

The Owlet Smart Sock has been used to monitor heart rate and oxygen levels in over 47,000 newborns, with most parents reporting better sleep quality and high acceptance of the device. No specific safety issues were reported in these studies, suggesting it is generally safe for newborns. ^{1 2 3 4 6}

How is the Owlet OSS 3.0 Sensor treatment different from other treatments for monitoring newborns?

The Owlet OSS 3.0 Sensor is unique because it is a wireless pulse oximeter, allowing for continuous and convenient monitoring of a newborn's heart rate and oxygen levels at home, unlike traditional wired devices typically used in hospitals. ^{1 2 4 7 8}

Research Team

Gwenyth Fischer, M.D.

Principal Investigator

University of Minnesota Medical Center

Michael A Brock, M.D.

Principal Investigator

University of Alabama Birmingham - Children's of Alabama

Eligibility Criteria

This trial is for newborns who weigh at least 1500 grams and are already undergoing arterial blood monitoring in a hospital. The study aims to include between 20 to 50 participants. Newborns with certain conditions that would interfere with the pulse oximeter's accuracy or those unable to undergo standard blood gas sampling may be excluded.

Inclusion Criteria

I already have an arterial line for blood tests as part of my treatment plan.

My baby is 44 weeks old or younger, counting from conception.

My weight is at least 1500g (3.3 pounds).

Exclusion Criteria

Subjects with underdeveloped skin as assessed by a study investigator and/or reported by the clinical care team

Subjects with abnormalities at the planned application sites that would interfere with system measurements (e.g., limb deformities, open wounds, severe edema)

Subjects on extracorporeal membrane oxygenation (ECMO) or other mechanical circulatory support

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants wear the Owlet OSS 3.0 Sensor for continuous SpO2 monitoring and comparison with arterial blood gas samples

48 hours

Continuous monitoring in hospital setting

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Owlet OSS 3.0 Sensor

Trial Overview The Owlet OSS 3.0 Sensor, part of the Owlet Dream Sock, is being tested for its accuracy in measuring oxygen levels and pulse rates in newborns compared to traditional arterial blood samples. This noninvasive device uses Bluetooth technology to transmit data.

Participant Groups

Group I: Owlet Arm Experimental Treatment 1 Intervention

All study participants meeting inclusion criteria with no stated exclusions will wear the Owlet OSS 3.0 Sensor during the study intervention. The Owlet OSS 3.0 Sensor may be placed continuously on a study subject for up to 48 hours with rotation to the opposite foot every 8 hours per device labeling to enable noninvasive data collection during the subject's standard of care blood draws. The Owlet base station will be activated in order to transmit readings but will not provide any external alarms or live displays during the monitoring period. No display of readings from the assigned Owlet device will be made available to the participant or the investigators during the time of data acquisition.

Who Is Running the Clinical Trial?

Owlet Baby Care, Inc.

Lead Sponsor

Trials

11

Recruited

9,600+

Children's of Alabama

Collaborator

Trials

10

Recruited

3,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

University of Minnesota Medical School/University of Minnesota Foundation

Collaborator

Trials

1

Recruited

20+

University Hospital at University of Alabama at Birmingham

Collaborator

Trials

1

Recruited

20+

Findings from Research

In a study of 100 low-risk newborns, the IntelliVue system measured heart rate (HR) significantly faster than the Nellcor pulse oximeter, with a median time of 24 seconds compared to 48 seconds (p<0.001).

The IntelliVue system also detected initial bradycardia more frequently (55% of cases) than the Nellcor system (6%), suggesting it may provide more immediate insights into the infants' heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised study comparing heart rate measurement in newly born infants using a monitor incorporating electrocardiogram and pulse oximeter versus pulse oximeter alone. Murphy, MC., De Angelis, L., McCarthy, LK., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Accuracy of Wireless Pulse Oximeter on Preterm or [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Inpatient comparison of wireless and wired pulse oximetry in neonates. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Newborn Pulse Oximetry Screening at a Community Hospital: An 8-Year Experience. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Initial Experience and Usage Patterns With the Owlet Smart Sock Monitor in 47,495 Newborns. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Using intermittent pulse oximetry to guide neonatal oxygen therapy in a low-resource context. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Association between Policy Changes for Oxygen Saturation Alarm Settings and Neonatal Morbidity and Mortality in Infants Born Very Preterm. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Pulse oximetry--an alternative to transcutaneous PO2 in sick newborns. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Randomised study comparing heart rate measurement in newly born infants using a monitor incorporating electrocardiogram and pulse oximeter versus pulse oximeter alone. [2019]