Remote Oximeter Monitoring for High-Risk Infants

(ROMPER Trial)

Overseen By Rachel Benz, MSN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Major malformation, Neuromuscular, Congenital heart, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

700 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called the Owlet OSS 3.0 pulse oximeter to determine if it reduces emergency room visits or rehospitalizations for high-risk infants after NICU discharge. The pulse oximeter monitors heart rate and oxygen levels during sleep, sounding an alarm for low levels and allowing caregivers to track these remotely via an app. Infants discharged from the NICU who no longer require breathing support might be suitable candidates for this trial. As an unphased trial, this study provides caregivers a unique opportunity to contribute to research that could enhance monitoring for high-risk infants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Owlet OSS 3.0 pulse oximeter is safe for high-risk infants?

Research shows that the Owlet OSS 3.0 pulse oximeter is safe for infants. Studies have found that it accurately tracks important health signs like heart rate and oxygen levels. This capability allows it to alert caregivers to potential health issues without causing unnecessary worry from false alarms. The device fits infants comfortably and securely.

The American Academy of Pediatrics recommends these monitors for high-risk babies, such as those born prematurely, indicating that the device suits this vulnerable group. Additionally, the FDA has approved it for use in healthy infants, further confirming its safety.

In summary, current evidence supports the safety of the Owlet OSS 3.0 pulse oximeter for monitoring infants, making it a reliable choice for parents of high-risk babies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Owlet OSS 3.0 pulse oximeter because it offers continuous, remote monitoring of high-risk infants' vital signs, unlike most standard practices which rely on periodic, in-person check-ups. This device provides real-time alerts for low heart rates or oxygen levels, giving caregivers and healthcare providers immediate information to act on. Additionally, the Owlet's integration with a smartphone app allows parents to track their baby's health data from anywhere with Wi-Fi, providing peace of mind and potentially reducing the need for frequent hospital visits.

What evidence suggests that the Owlet OSS 3.0 pulse oximeter is effective for reducing emergency room visits and rehospitalizations in high-risk infants?

Research has shown that the Owlet OSS 3.0 pulse oximeter effectively monitors vital signs in babies. Studies have found it correctly identifies low oxygen levels (hypoxemia) 88.8% of the time and accurately rules out false alarms for low heart rate (bradycardia) 100% of the time. Many parents report feeling more secure using this device, with 94% stating it improves their sense of safety for their newborns. In this trial, babies in the Owlet monitor group will use this device to track heart rate and oxygen levels, providing caregivers with a reliable way to monitor their baby's health. ^{1 2 3 6 7}

Who Is on the Research Team?

Colm P Travers, M.D.

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for high-risk infants being discharged from the NICU. They must be off all respiratory support, born at or after 22 weeks' gestation, and have parental consent to participate. Specific details on who cannot join are not provided.

Inclusion Criteria

My infant is being discharged from the NICU.

My baby was born at or after 22 weeks of pregnancy.

My parents or legal guardians have agreed to my participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Remote patient monitoring using an Owlet OSS 3.0 pulse oximeter for infants in the intervention group

6 months

Monthly surveys or questionnaires

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Owlet OSS 3.0 pulse oximeter

Trial Overview The study tests if using an Owlet OSS 3.0 pulse oximeter for remote monitoring can reduce emergency room visits and rehospitalizations in these infants after they leave the NICU.

How Is the Trial Designed?

Group I: Babies in the Owlet monitor group Experimental Treatment 1 Intervention

The Owlet group will be given an Owlet OSS 3.0 monitor to wear when sleeping. The Owlet alarms if the baby has a very low heart rate or very low oxygen levels. In addition, caregivers in the Owlet group with a smart phone and Wi-Fi access will be able to use an application to monitor the baby's vital signs and sleep state. Will complete a survey or questionnaire every month until 6 months after discharge.

Group II: Babies in the Usual Care Group Active Control 1 Intervention

The usual care group will not be given an Owlet vital sign monitor. Will complete a survey or questionnaire every month until 6 months after discharge.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Owlet Baby Care, Inc.

Industry Sponsor

Trials

11

Recruited

9,600+

Citations

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

Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in ... 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 ...

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. 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.

4. 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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06850610

Accuracy Of The Owlet OSS 3.0 During Standardized ... This study will be evaluating the Owlet OSS 3.0 sensor, a component in 2 FDA cleared noninvasive pulse oximeters indicated for infants 1-18 months of age.

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

DEN220091, Dream Sock, Owlet - accessdata.fda.gov The device is intended to monitor healthy infants 1 to 18 months ofage and between 6 to 30 lbs. The device includes alarms to alert the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12353594/

The Diagnostic Accuracy of an Over-The-Counter Infant ... Conclusion: An over-the-counter infant pulse oximeter had high specificity for bradycardia and hypoxemia events consistent with a low false alarm rate. ...