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

NCT06565390 | Recruiting DMC FDA Device

• 2 other identifiers: 300013146OSP 000545308
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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 rehospitalizations among high-risk infants after NICU discharge.

Conditions

Emergencies

Outcome Measures

Primary Outcomes (1)

• Emergency room visits and high-acuity rehospitalizations.

  Number of emergency room visits and high-acuity rehospitalizations.

  6 months

Secondary Outcomes (11)

• Number of participants with serious outcome events

  6 months

• High-acuity rehospitalizations

  6 months

• All-cause mortality.

  6 months

• Other rehospitalizations

  6 months

• Emergency room visits

  6 months

Study Arms (2)

Babies in the Owlet monitor group

EXPERIMENTAL

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.

Device: Babies in the Owlet monitor group

Babies in the Usual Care Group

NO INTERVENTION

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.

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.

Babies in the Owlet monitor group

Eligibility Criteria

• Age: 22 Weeks - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Owlet Baby Care, Inc.: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

RECRUITING

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Colm P Travers, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Armstead, BS

CONTACT

205-934-0095; karmstead@uabmc.edu

Rachel Benz, MSN

CONTACT

205-934-4680; rbenz@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study will have two groups. One group will use the Owlet OSS 3.0 pulse oximeter and the other group will not.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 22, 2024
• Study Start: September 11, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)