Clinical trial NCT06565390: Remote Oximeter Monitoring Post-discharge to Reduce Emergency Room Visits and Rehospitalization
Official title: Remote Oximeter Monitoring Post-discharge to Reduce Emergency Room Visits and Rehospitalization (ROMPER): a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emergencies
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Owlet Baby Care, Inc.
First posted: 2024-08-22
Enrollment: 700
Sex: ALL
Minimum age (years): 22
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will have two groups. One group will use the Owlet OSS 3.0 pulse oximeter and the other group will not.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Emergency room visits and high-acuity rehospitalizations.
timeFrame: 6 months
Secondary outcomes:
measure: Number of participants with serious outcome events
timeFrame: 6 months
measure: High-acuity rehospitalizations
timeFrame: 6 months
measure: All-cause mortality.
timeFrame: 6 months
measure: Other rehospitalizations
timeFrame: 6 months
measure: Emergency room visits
timeFrame: 6 months
measure: Sick visits
timeFrame: 6 months
measure: Apparent life-threatening event (ALTE/ Brief resolved unexplained event (BRUE)
timeFrame: 6 months
measure: Healthcare utilization
timeFrame: 6 months
measure: Safe-sleep practice adherence
timeFrame: 6 months
measure: Caregiver sleep disturbance.
timeFrame: 6 months
measure: Caregiver anxiety score.
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Colm P Travers, M.D.
role: PRINCIPAL_INVESTIGATOR
References: