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.
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
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.
Parallel
Babies in the Owlet monitor group
DeviceThe 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.
Emergency room visits and high-acuity rehospitalizations.
Number of emergency room visits and high-acuity rehospitalizations.
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.
High-acuity rehospitalizations
The number of high-acuity rehospitalizations.
All-cause mortality.
The rate of all-cause mortality.
Other rehospitalizations
The number of other rehospitalizations.
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
Owlet Baby Care, Inc.
Collaborator
