Remote Oximeter Monitoring Post-discharge to Reduce Emergency Room Visits and Rehospitalization (ROMPER)

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.

Study Overview

• Status: Recruiting
• Conditions: Emergencies
• Intervention / Treatment: Device: Babies in the Owlet monitor group

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 Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kimberly Armstead, BS; Phone Number: 205-934-0095; Email: karmstead@uabmc.edu
• Study Contact Backup: Name: Rachel Benz, MSN; Phone Number: 205-934-4680; Email: rbenz@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Colm Travers, MD; Phone Number: 2053545008; Email: colmtravers@hotmail.com
      • Contact: Kimberly Armstead, BS; Email: karmstead@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Babies in the Owlet monitor group; 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.	Device: Babies in the Owlet monitor group; 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.
No Intervention: Babies in the Usual Care Group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency room visits and high-acuity rehospitalizations.	Number of emergency room visits and high-acuity rehospitalizations.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
High-acuity rehospitalizations	The number of high-acuity rehospitalizations.	6 months
All-cause mortality.	The rate of all-cause mortality.	6 months
Other rehospitalizations	The number of other rehospitalizations.	6 months
Emergency room visits	The number of emergency room visits.	6 months
Sick visits	The number of sick visits mediated by wearing Owlet OSS 3.0 Sock while sleeping.	6 months
Apparent life-threatening event (ALTE/ Brief resolved unexplained event (BRUE)	Number of episodes of ALTE/BRUE	6 months
Healthcare utilization	Healthcare utilization in cost effectiveness analysis	6 months
Safe-sleep practice adherence	Number of participant caregivers reporting adherence to safe-sleep practices on questionnaire.	6 months
Caregiver sleep disturbance.	Caregiver sleep disturbance using the sleep quality scale.	6 months
Caregiver anxiety score.	Caregiver anxiety score assessed using State Trait Anxiety Inventory.	6 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Owlet Baby Care, Inc.
• Investigators: Principal Investigator: Colm P Travers, M.D., University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Emergencies
• Other Study ID Numbers: 300013146; OSP 000545308 (Other Grant/Funding Number: Owlet Baby Care Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will only share aggregate data with the study sponsor and with data analyst.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes