Status:
RECRUITING
Remote Oximeter Monitoring Post-discharge to Reduce Emergency Room Visits and Rehospitalization
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Owlet Baby Care, Inc.
Conditions:
Emergencies
Eligibility:
All Genders
22-6 years
Phase:
NA
Brief 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 rehospitalizati...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT06565390
Start Date
September 11 2025
End Date
December 31 2030
Last Update
September 30 2025
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249