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NCT Number: NCT06565390

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

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.

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Key information

Conditions

Emergencies Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

22 week–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Babies in the Owlet monitor group

Device

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.

Primary outcomes

  1. Emergency room visits and high-acuity rehospitalizations.

    Time frame: 6 months

    Number of emergency room visits and high-acuity rehospitalizations.

Secondary outcomes

  1. Number of participants with serious outcome events

    Time frame: 6 months

    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.

  2. High-acuity rehospitalizations

    Time frame: 6 months

    The number of high-acuity rehospitalizations.

  3. All-cause mortality.

    Time frame: 6 months

    The rate of all-cause mortality.

  4. Other rehospitalizations

    Time frame: 6 months

    The number of other rehospitalizations.

  5. Emergency room visits

    Time frame: 6 months

    The number of emergency room visits.

  6. Sick visits

    Time frame: 6 months

    The number of sick visits mediated by wearing Owlet OSS 3.0 Sock while sleeping.

  7. Apparent life-threatening event (ALTE/ Brief resolved unexplained event (BRUE)

    Time frame: 6 months

    Number of episodes of ALTE/BRUE

  8. Healthcare utilization

    Time frame: 6 months

    Healthcare utilization in cost effectiveness analysis

  9. Safe-sleep practice adherence

    Time frame: 6 months

    Number of participant caregivers reporting adherence to safe-sleep practices on questionnaire.

  10. Caregiver sleep disturbance.

    Time frame: 6 months

    Caregiver sleep disturbance using the sleep quality scale.

  11. Caregiver anxiety score.

    Time frame: 6 months

    Caregiver anxiety score assessed using State Trait Anxiety Inventory.

Study contacts

Contact information is provided by the study sponsor or research team.

Kimberly Armstead, BS

CONTACT

[email protected]

205-934-0095

Rachel Benz, MSN

CONTACT

[email protected]

205-934-4680

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Owlet Baby Care, Inc.

Registry information

Official study title

Remote Oximeter Monitoring Post-discharge to Reduce Emergency Room Visits and Rehospitalization (ROMPER): A Randomized Clinical Trial

Acronym: ROMPER

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Aug 22, 2024
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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