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NCT06565390NARecruiting

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

University of Alabama at Birmingham

Start Date

9/11/2025

Completion Date

12/31/2030

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.

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.

Eligibility Criteria

Age Range: No minimum to No maximum

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.

Interventions

DEVICE

Babies in the Owlet monitor group

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Conditions

Emergencies

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35249

United States