Emergencies
Conditions
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.
Interventions
DEVICEBabies 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.
Sponsors
Owlet Baby Care, Inc.
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
22 Weeks to 6 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergency room visits and high-acuity rehospitalizations. | 6 months | Number of emergency room visits and high-acuity rehospitalizations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| High-acuity rehospitalizations | 6 months | The number of high-acuity rehospitalizations. |
| All-cause mortality. | 6 months | The rate of all-cause mortality. |
| Other rehospitalizations | 6 months | The number of other rehospitalizations. |
| Emergency room visits | 6 months | The number of emergency room visits. |
| Sick visits | 6 months | The number of sick visits mediated by wearing Owlet OSS 3.0 Sock while sleeping. |
| 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. |
| Healthcare utilization | 6 months | Healthcare utilization in cost effectiveness analysis |
| 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. |
| Caregiver anxiety score. | 6 months | Caregiver anxiety score assessed using State Trait Anxiety Inventory. |
| Apparent life-threatening event (ALTE/ Brief resolved unexplained event (BRUE) | 6 months | Number of episodes of ALTE/BRUE |
Countries
United States
Contacts
Primary ContactKimberly Armstead, BS
Backup ContactRachel Benz, MSN
Outcome results
None listed