EmergenciesROMPERNCT06565390
Remote Oximeter Monitoring Post-discharge to Reduce Emergency Room Visits and Rehospitalization
A study testing Babies in the Owlet monitor group in people with Emergencies, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This randomized clinical trial will determine the efficacy of remote patient monitoring using an Owlet OSS 3.0 pulse oximeter for the reduction of emergency room visits and high-acuity rehospitalizations among high-risk infants after NICU discharge. Read more about this study
- Who is it for?
- Ages 22 weeks to 6 months
- Conditions the study is for
- Emergencies
- What is being tested?
- Babies in the Owlet monitor group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2025to 31 Dec 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 weeks to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants being discharged from the NICU
- Off all respiratory support (oxygen, CPAP, ventilator) before discharge home
- Gestational age ≥ 22 0/7 weeks' gestation at birth
- Parents/legal guardians have provided consent for enrollment
Who cannot join
- a major malformation, a neuromuscular condition that affects respiration or causes apnea, complex congenital heart disease and hemodynamically significant shunts, or terminal illness or decision to withhold or limit support.
- Infants being discharged from the neonatal intensive care unit (NICU) with a cardiorespiratory monitor or respiratory support are not eligible for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this study
Official title: Remote Oximeter Monitoring Post-discharge to Reduce Emergency Room Visits and Rehospitalization (ROMPER): A Randomized Clinical Trial
This randomized clinical trial will determine the efficacy of remote patient monitoring using an Owlet OSS 3.0 pulse oximeter for the reduction of emergency room visits and high-acuity rehospitalizations among high-risk infants after NICU discharge.
Read the detailed description
To determine if among infants being discharged from the neonatal intensive care unit (NICU) without a cardiorespiratory monitor or respiratory support, remote patient monitoring using an Owlet OSS 3.0 pulse oximeter (Owlet, Lehi, UT) decreases emergency room visits and high-acuity rehospitalizations after discharge compared with routine care.
Infants being discharged from the neonatal intensive care unit (NICU) without a cardiorespiratory monitor or respiratory support are eligible for inclusion.
The Investigators will provide remote patient monitoring using an Owlet OSS 3.0 pulse oximeter to infants in the intervention group for a 6 month period. The Investigators will collect monthly outcome measures from caregivers of all infants.
- Conditions
- Emergencies
- Being tested
- Babies in the Owlet monitor group
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Babies in the Owlet monitor groupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Babies in the Owlet monitor group | Experimental | 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. Receives: Device: Babies in the Owlet monitor group |
| Babies in the Usual Care Group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency room visits and high-acuity rehospitalizations.
Number of emergency room visits and high-acuity rehospitalizations.
Measured: 6 months
Secondary outcomes (11)
Number of participants with serious outcome events
The number of participants with serious adverse event composite outcome: includes death, medical provider delivered cardiac pulmonary resuscitation (CPR), receipt of positive airway pressure, or intubation during study period.
Measured: 6 months
High-acuity rehospitalizations
The number of high-acuity rehospitalizations.
Measured: 6 months
All-cause mortality.
The rate of all-cause mortality.
Measured: 6 months
Other rehospitalizations
The number of other rehospitalizations.
Measured: 6 months
Emergency room visits
The number of emergency room visits.
Measured: 6 months
Sick visits
The number of sick visits mediated by wearing Owlet OSS 3.0 Sock while sleeping.
Measured: 6 months
Apparent life-threatening event (ALTE/ Brief resolved unexplained event (BRUE)
Number of episodes of ALTE/BRUE
Measured: 6 months
Healthcare utilization
Healthcare utilization in cost effectiveness analysis
Measured: 6 months
Safe-sleep practice adherence
Number of participant caregivers reporting adherence to safe-sleep practices on questionnaire.
Measured: 6 months
Caregiver sleep disturbance.
Caregiver sleep disturbance using the sleep quality scale.
Measured: 6 months
Caregiver anxiety score.
Caregiver anxiety score assessed using State Trait Anxiety Inventory.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start11 Sep 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will have two groups. One group will use the Owlet OSS 3.0 pulse oximeter and the other group will not.
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Owlet Baby Care, Inc.
- Responsible party
- Principal investigator, Colm Travers, University of Alabama at Birmingham
- Investigators
- Colm P Travers, M.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565390
- Sponsor's protocol ID
- 300013146
- Other IDs
- OSP 000545308
- Acronym
- ROMPER
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We will only share aggregate data with the study sponsor and with data analyst.