Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565390
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Remote Oximeter Monitoring Post-discharge to Reduce Emergency Room Visits and Rehospitalization
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Remote Oximeter Monitoring Post-discharge to Reduce Emergency Room Visits and Rehospitalization ROMPER a Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROMPER
Brief Summary:
This randomized clinical trial will determine the efficacy of remote patient monitoring using an Owlet OSS 30 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 30 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 30 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
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 30 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None