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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Oximeter Monitoring Post-discharge to Reduce Emergency Room Visits and Rehospitalization (ROMPER): A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06565390
- Acronym / sponsor ID
- ROMPER / 300013146
- Conditions
- Emergencies
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Owlet Baby Care, Inc.
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Babies in the Owlet monitor group | Experimental | Device: Babies in the Owlet monitor groupThe 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. |
| 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. |
Who may qualify
- Ages
- 22 weeks to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Babies in the Owlet monitor groupThe 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. | Device | Babies in the Owlet monitor group |
Primary outcome
Emergency room visits and high-acuity rehospitalizations.
Time frame: 6 months
Number of emergency room visits and high-acuity rehospitalizations.
11 secondary outcomes
Number of participants with serious outcome events
Time frame: 6 months
High-acuity rehospitalizations
Time frame: 6 months
All-cause mortality.
Time frame: 6 months
Other rehospitalizations
Time frame: 6 months
Emergency room visits
Time frame: 6 months
Sick visits
Time frame: 6 months
Apparent life-threatening event (ALTE/ Brief resolved unexplained event (BRUE)
Time frame: 6 months
Healthcare utilization
Time frame: 6 months
Safe-sleep practice adherence
Time frame: 6 months
Caregiver sleep disturbance.
Time frame: 6 months
Caregiver anxiety score.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. We will only share aggregate data with the study sponsor and with data analyst.
Related trials for Emergencies
Recruiting
Developing a Support Application for Food Pantries (SAFPAS) to Improve Client Access to Healthy Foods & Enhance Emergency Preparedness
Improving Healthy Food Access in Food Insecurity Populations in Normal and Emergency Situations
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
Preventing Suicidal Behavior With Diverse High-Risk Youth in Acute Care Settings
Suicide, Attempted, Suicide Ideation
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Colm P Travers, M.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency room visits and high-acuity rehospitalizations. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.