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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06565390
Status
Recruiting
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Conditions

  • Emergencies

Eligibility Criteria

Sex
ALL
Age
22 Weeks - 6 Months
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Sep 11, 2025
Status verified
Sep 2025
Primary completion
Oct 31, 2027
Completion
Dec 31, 2030

Study Design

Enrollment
700 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.
  • 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.

Primary Outcome Measure

Emergency room visits and high-acuity rehospitalizations. [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35249
Colm Travers, MD
[email protected]
2053545008
Kimberly Armstead, BS
[email protected]

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By research site
University of Alabama at Birmingham· Birmingham, AL

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