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Recruiting NCT06565390

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

No phase Interventional Emergencies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Babies in the Owlet monitor group.
Who it may be relevant to
Registry conditions: Emergencies. Basic parameters: 22 Weeks — 6 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Remote Oximeter Monitoring Post-discharge to Reduce Emergency Room Visits and Rehospitalization (ROMPER): A Randomized Clinical Trial

Overview

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.

Interventions

  • Device Babies in the Owlet monitor group
    The 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.

Primary outcome measures

  • Emergency room visits and high-acuity rehospitalizations. [Time frame: 6 months]
Secondary outcome measures (11)
  • Number of participants with serious outcome events [Time frame: 6 months]
  • High-acuity rehospitalizations [Time frame: 6 months]
  • All-cause mortality. [Time frame: 6 months]
  • Other rehospitalizations [Time frame: 6 months]
  • Emergency room visits [Time frame: 6 months]
  • Sick visits [Time frame: 6 months]
  • Apparent life-threatening event (ALTE/ Brief resolved unexplained event (BRUE) [Time frame: 6 months]
  • Healthcare utilization [Time frame: 6 months]
  • Safe-sleep practice adherence [Time frame: 6 months]
  • Caregiver sleep disturbance. [Time frame: 6 months]
  • Caregiver anxiety score. [Time frame: 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Alabama at Birmingham — Birmingham

Identifiers

NCT: NCT06565390 · 300013146 · OSP 000545308

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗