The Effects of Home Monitors Used with Home Oxygen Therapy
The Effects of Home Monitors Used with Home Oxygen Therapy: a Randomized Control Trial
Study Overview
Status
Intervention / Treatment
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 participant's home.
Exploratory Aim 1: Determine the perceptions of families regarding home monitor use.
Study Type
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Infants being discharged with home oxygen therapy.
- Infants born at other institutions and then transferred to UNMH will be eligible if discharged home with home oxygen therapy.
- Infants born at gestational age 28 0/7 weeks or greater.
- Infants of employees of the UNMH will be allowed to participate in the study but will not be targeted. All efforts will be made to ensure that no coercion or undue influence will be used in recruiting this population.
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.
- Infants discharged with hospice care / palliative services.
- Infants discharged greater than 6 months after they were born.
- Parents less than 18 years old or prisoners.
- Parents who are unable to provide consent due to having a legal representative.
- Infants who are in foster care and/or are wards of the state.
- Families not fluent in English.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Home oxygen monitor
Infant will be on a home oxygen weaning guideline for their pediatrician to used based on information form the home oxygen monitor
|
Weaning of home oxygen using information gathered from home moniotr devise
|
|
Active Comparator: No Home oxygen monitor
Infant will have a home oxygen weaning guideline for their pediatrician to use based on parameters other than a home oxygen monitor
|
Weaning of home oxygen using information gathered from home moniotr devise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oxygen Wean
Time Frame: 1 -2 months
|
Length of time it takes infant to get off home oxygen
|
1 -2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dawn Novak, MD, University of New Mexico Children's Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 24-105:Home Oxygen Monitors
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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