Remote Oximeter Monitoring Post-discharge to Reduce Emergency Room Visits and Rehospitalization
- Conditions
- Emergencies
- Interventions
- Device: Babies in the Owlet monitor group
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 700
- 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
- 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
- Arm && Interventions
Group Intervention Description Babies in the Owlet monitor group 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. Will complete a survey or questionnaire every month until 6 months after discharge.
- 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.