Remote Oximeter Monitoring Post-discharge to Reduce Emergency Room Visits and Rehospitalization
NCT ID: NCT06565390
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
700 participants
INTERVENTIONAL
2025-09-11
2030-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Infants being discharged from the neonatal intensive care unit (NICU) with a cardiorespiratory monitor or respiratory support are not eligible for inclusion.
22 Weeks
6 Months
ALL
No
Sponsors
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Owlet Baby Care, Inc.
INDUSTRY
University of Alabama at Birmingham
OTHER
Responsible Party
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Colm Travers
Assistant Professor
Principal Investigators
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Colm P Travers, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OSP 000545308
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
300013146
Identifier Type: -
Identifier Source: org_study_id
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