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| ID | Type | Description | Link |
|---|---|---|---|
| OSP 000545308 | Other Grant/Funding Number | Owlet Baby Care Inc. |
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| Name | Class |
|---|---|
| Owlet Baby Care, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Babies in the Owlet monitor group | Experimental | 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. |
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| Babies in the Usual Care Group | No Intervention | The usual care group will not be given an Owlet vital sign monitor. Will complete a survey or questionnaire every month until 6 months after discharge. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Babies in the Owlet monitor group | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Emergency room visits and high-acuity rehospitalizations. | Number of emergency room visits and high-acuity rehospitalizations. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with serious outcome events | 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. | 6 months |
| High-acuity rehospitalizations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Armstead, BS | Contact | 205-934-0095 | karmstead@uabmc.edu | |
| Rachel Benz, MSN | Contact | 205-934-4680 | rbenz@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Colm P Travers, M.D. | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35249 | United States |
We will only share aggregate data with the study sponsor and with data analyst.
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The study will have two groups. One group will use the Owlet OSS 3.0 pulse oximeter and the other group will not.
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|
The number of high-acuity rehospitalizations. |
| 6 months |
| All-cause mortality. | The rate of all-cause mortality. | 6 months |
| Other rehospitalizations | The number of other rehospitalizations. | 6 months |
| Emergency room visits | The number of emergency room visits. | 6 months |
| Sick visits | The number of sick visits mediated by wearing Owlet OSS 3.0 Sock while sleeping. | 6 months |
| Apparent life-threatening event (ALTE/ Brief resolved unexplained event (BRUE) | Number of episodes of ALTE/BRUE | 6 months |
| Healthcare utilization | Healthcare utilization in cost effectiveness analysis | 6 months |
| Safe-sleep practice adherence | Number of participant caregivers reporting adherence to safe-sleep practices on questionnaire. | 6 months |
| Caregiver sleep disturbance. | Caregiver sleep disturbance using the sleep quality scale. | 6 months |
| Caregiver anxiety score. | Caregiver anxiety score assessed using State Trait Anxiety Inventory. | 6 months |