Remote Oximeter Monitoring Post-discharge to Reduce Emergency Room Visits and Rehospitalization (ROMPER): A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Emergencies
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 700
- Locations
- 1
- Primary Endpoint
- Emergency room visits and high-acuity rehospitalizations.
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
Colm Travers
Assistant Professor
University of Alabama at Birmingham
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Emergency room visits and high-acuity rehospitalizations.
Time Frame: 6 months
Number of emergency room visits and high-acuity rehospitalizations.
Secondary Outcomes
- Number of participants with serious outcome events(6 months)
- High-acuity rehospitalizations(6 months)
- Apparent life-threatening event (ALTE/ Brief resolved unexplained event (BRUE)(6 months)
- Caregiver anxiety score.(6 months)
- All-cause mortality.(6 months)
- Other rehospitalizations(6 months)
- Safe-sleep practice adherence(6 months)
- Caregiver sleep disturbance.(6 months)
- Sick visits(6 months)
- Healthcare utilization(6 months)
- Emergency room visits(6 months)