Ignite Creation Date:
2024-07-17 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492382
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
The Effects of Home Monitors Used With Home Oxygen Therapy
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
The Effects of Home Monitors Used With Home Oxygen Therapy A Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study39s purpose is to determine the effects of using monitors with home oxygen therapy HOT This trial will test the hypothesis that infants discharged from the neonatal intensive care unit NICU with HOT will have a shorter treatment duration if used in conjunction with monitors
Detailed Description:
This will be a randomized control trial in which infants being discharged from the neonatal intensive care unit with home oxygen therapy will be placed in one of two groups Those randomized into the treatment group will be sent home with a monitor to be used continuously during their need for supplemental oxygen The control group will consist of infants randomized to receive the current standard of care which is discharge with home oxygen and NO home monitor The research team will contact the families of the subjects at one-month intervals to collect pertinent data
Aim 1 Subjects will be randomly assigned to a control group no home monitors which is current clinical practice and an experimental group home monitors The investigators will compare the duration of treatment with HOT between groups
Aim 2 Obtain additional data from study participants to better understand the impact of home monitoring This data includes frequency of adverse events defined later in the protocol including health care utilization as well as parental quality of life and altitude of the participant39s home
Exploratory Aim 1 Determine the perceptions of families regarding home monitor use
Aim 1 Subjects will be randomly assigned to a control group no home monitors which is current clinical practice and an experimental group home monitors The investigators will compare the duration of treatment with HOT between groups
Aim 2 Obtain additional data from study participants to better understand the impact of home monitoring This data includes frequency of adverse events defined later in the protocol including health care utilization as well as parental quality of life and altitude of the participant39s home
Exploratory Aim 1 Determine the perceptions of families regarding home monitor use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None