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

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Emergencies

Treatments: Device: Babies in the Owlet monitor group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06565390

300013146

OSP 000545308 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 700 estimated patients

Sex: All

Ages: 22 weeks to 6 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

700 participants in 2 patient groups

Babies in the Owlet monitor group

Experimental group

Description:

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.

Treatment:

Device: Babies in the Owlet monitor group

Babies in the Usual Care Group

No Intervention group

Description:

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.