RecruitingNot ApplicableNCT06565390

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

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


Sponsor

University of Alabama at Birmingham

Enrollment

700 participants

Start Date

Sep 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 22 WeeksMax Age: 6 Months

Inclusion Criteria4

  • 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 Criteria2

  • 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.

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Interventions

DEVICEBabies 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.


Locations(1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

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NCT06565390


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