About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Treatments tested in this trial
- Babies in the Owlet monitor group
Treatment groups
Sponsors and collaborators
University of Alabama at Birmingham
Lead sponsor
Owlet Baby Care, Inc.
Collaborator