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

University of Alabama at Birmingham700 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

700

Conditions

Emergencies

Interventions

Babies in the Owlet monitor groupDEVICE

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

Sex: ALLMin age: 22 WeeksMax age: 6 Months

Medical Language ↔ Plain English

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.

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

RECRUITING

Outcomes

Primary Outcomes

Emergency room visits and high-acuity rehospitalizations.

Number of emergency room visits and high-acuity rehospitalizations.

Time frame: 6 months

Secondary Outcomes

Number of participants with serious outcome events

The number of participants with serious adverse event composite outcome: includes death, medical provider delivered cardiac pulmonary resuscitation (CPR), receipt of positive airway pressure, or intubation during study period.

Time frame: 6 months

High-acuity rehospitalizations

The number of high-acuity rehospitalizations.

Time frame: 6 months

All-cause mortality.

The rate of all-cause mortality.

Time frame: 6 months

Other rehospitalizations

The number of other rehospitalizations.

Time frame: 6 months

Emergency room visits

The number of emergency room visits.

Time frame: 6 months

Sick visits

The number of sick visits mediated by wearing Owlet OSS 3.0 Sock while sleeping.

Time frame: 6 months

Apparent life-threatening event (ALTE/ Brief resolved unexplained event (BRUE)

Number of episodes of ALTE/BRUE

Time frame: 6 months

Central Contacts

Kimberly Armstead, BS

CONTACT

205-934-0095 karmstead@uabmc.edu

Rachel Benz, MSN

CONTACT

205-934-4680 rbenz@uabmc.edu

Data from ClinicalTrials.gov

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