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Per PI, the team couldn't get the home oxygen monitors needed for the study
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This study's 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.
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 participant's home.
Exploratory Aim 1: Determine the perceptions of families regarding home monitor use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home oxygen monitor | Experimental | Infant will be on a home oxygen weaning guideline for their pediatrician to used based on information form the home oxygen monitor |
|
| No Home oxygen monitor | Active Comparator | Infant will have a home oxygen weaning guideline for their pediatrician to use based on parameters other than a home oxygen monitor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home Oxygen Monitors | Diagnostic Test | Weaning of home oxygen using information gathered from home moniotr devise |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Wean | Length of time it takes infant to get off home oxygen | 1 -2 months |
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Inclusion Criteria:
• Infants being discharged with home oxygen therapy.
Exclusion Criteria:
• Infants diagnosed with conditions that will predispose them to prolonged hypoxemia; examples include cardiac anomaly, anatomic anomalies affecting the airway, tracheostomy dependency, cystic fibrosis, and trisomy 21.
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| Name | Affiliation | Role |
|---|---|---|
| Dawn Novak, MD | University of New Mexico Children's Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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