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

Not Applicable

Not yet recruiting

• Conditions: Emergencies

• Registration Number: NCT06565390
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-07-29
• Study First Submitted QC: 2024-08-19
• Study First Posted: 2024-08-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07
• Study Start: 2025-07-01
• Primary Completion: 2027-10-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 700

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Emergency room visits and high-acuity rehospitalizations.	6 months	Number of emergency room visits and high-acuity rehospitalizations.

Secondary Outcome Measures

Name	Time	Method
Number of participants with serious outcome events	6 months	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	6 months	The number of high-acuity rehospitalizations.
Apparent life-threatening event (ALTE/ Brief resolved unexplained event (BRUE)	6 months	Number of episodes of ALTE/BRUE
Caregiver anxiety score.	6 months	Caregiver anxiety score assessed using State Trait Anxiety Inventory.
All-cause mortality.	6 months	The rate of all-cause mortality.
Other rehospitalizations	6 months	The number of other rehospitalizations.
Safe-sleep practice adherence	6 months	Number of participant caregivers reporting adherence to safe-sleep practices on questionnaire.
Caregiver sleep disturbance.	6 months	Caregiver sleep disturbance using the sleep quality scale.
Sick visits	6 months	The number of sick visits mediated by wearing Owlet OSS 3.0 Sock while sleeping.
Healthcare utilization	6 months	Healthcare utilization in cost effectiveness analysis
Emergency room visits	6 months	The number of emergency room visits.