The Effects of Home Monitors Used with Home Oxygen Therapy: a Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of New Mexico
- Enrollment
- 20
- Primary Endpoint
- Oxygen Wean
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
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
Intervention: Home Oxygen Monitors (Diagnostic Test)
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
Intervention: Home Oxygen Monitors (Diagnostic Test)
Outcomes
Primary Outcomes
Oxygen Wean
Time Frame: 1 -2 months
Length of time it takes infant to get off home oxygen
Secondary Outcomes
No secondary outcomes reported
Investigators
Dawn Walstrom Novak
Associate Professor of Pediatrics
University of New Mexico