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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well the Owlet OSS 3.0 Sensor measures oxygen levels in newborns compared to standard hospital blood tests. The Owlet Sensor, a small device attached to a baby's foot, tracks oxygen levels, heart rate, and movement. Newborns weighing at least 1500 grams who are already undergoing blood tests as part of their normal care may be suitable candidates. The goal is to ensure the Owlet Sensor's accuracy for babies up to 28 days old. As an unphased trial, this study provides a unique opportunity to advance newborn care technology.

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 prior data suggests that the Owlet OSS 3.0 Sensor is safe for newborns?

Research has shown that the Owlet OSS 3.0 Sensor, used in the Owlet Dream Sock, is generally safe for babies. The FDA has approved the device for infants aged 1 to 18 months who weigh between 6 and 30 pounds, indicating it has passed several safety checks for this age group and weight range.

The Owlet Sensor is noninvasive, meaning it doesn't break the skin. It wraps around a baby's foot to monitor vital signs like oxygen levels and heart rate. The materials used in the device are hypoallergenic, reducing the likelihood of allergic reactions, and have been tested for safety in infants.

Some reports mention concerns about false alarms and inconsistent detection of low oxygen levels. While these issues don't directly affect safety, they could impact the overall experience of using the device.

Overall, the Owlet OSS 3.0 Sensor appears to be well-tolerated in infants, as supported by its FDA approval for older babies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Owlet OSS 3.0 Sensor because it offers a noninvasive way to monitor newborns' oxygen levels continuously. Unlike traditional methods, which often involve periodic blood draws or bulky equipment, this sensor is lightweight and can be worn on the baby's foot, allowing for seamless, uninterrupted data collection. Furthermore, the device operates discreetly without providing real-time alarms or displays, minimizing disturbances to the newborn's environment while still transmitting essential data to healthcare providers.

What evidence suggests that the Owlet OSS 3.0 Sensor is effective for monitoring oxygen levels in newborns?

Research has shown that the Owlet OSS 3.0 Sensor, which participants in this trial will use, effectively measures blood oxygen levels in newborns. Studies have found that the sensor correctly identifies low oxygen levels 88.8% of the time and avoids false alarms 85.7% of the time. It accurately detects low heart rates 100% of the time, ensuring no false alarms for this issue. Parents using the Owlet technology report increased confidence in monitoring their newborns. This suggests that the Owlet OSS 3.0 Sensor could reliably track newborns' oxygen levels and heart rates without invasive methods. ^{1 2 4 6 7}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06771206

Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in ... This is a prospective, non-randomized, single arm study to evaluate SpO2 performance of the Owlet OSS 3.0 pulse oximetry Sensor in the neonate population up to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7849797/

Media Review: The Owlet Smart Sock—a “must have” for ... The authors reported that the sensitivity and specificity of the Owlet for hypoxemia was 88.8% and 85.7%, respectively, and for bradycardia was 0.0% and 100.0%, ...

3. withpower.com withpower.com/trial/phase-pulse-oximeter-validation-1-2025-cdca1

Owlet Pulse Oximeter 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 ...

4. fn.bmj.com fn.bmj.com/content/early/2025/05/12/archdischild-2025-328540

Diagnostic accuracy of an over-the-counter infant pulse ... An over-the-counter infant pulse oximeter had high specificity for bradycardia and hypoxaemia events consistent with a low false alarm rate.

5. trial.medpath.com trial.medpath.com/clinical-trial/eff49fc5b11c675e/nct06771206-owlet-oss-30-sensor-neonatal-accuracy

Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in the ... This is a prospective, non-randomized, single arm study to evaluate SpO2 performance of the Owlet OSS 3.0 pulse oximetry Sensor in the neonate ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN220091.pdf

DEN220091, Dream Sock, Owlet - accessdata.fda.gov The Dream Sock does not detect, diagnose or reduce Sudden Infant Death Syndrome (SIDS) or Sudden Unexpected Infant Death (SUID). The Owlet ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5718309/

Initial Experience and Usage Patterns With the Owlet Smart ... ... newborns to children 15 to 18 months of age). The materials used for the OSS are durable, hypoallergenic, and safety tested for infant use.