Frequency of Adverse Events, Health Care Utilization, Infant Growth, Parental Quality of Life, and Altitude of the Participant's HomeNCT06492382
The Effects of Home Monitors Used with Home Oxygen Therapy
A study testing Home Oxygen Monitors in people with Frequency of Adverse Events, Health Care Utilization, Infant Growth, Parental Quality of Life, and Altitude of the Participant's Home, run by University of New Mexico.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Frequency of Adverse Events, Health Care Utilization, Infant Growth, Parental Quality of Life, and Altitude of the Participant's Home
- What is being tested?
- Home Oxygen Monitors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 8 Feb 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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.
About this study
Official title: The Effects of Home Monitors Used with Home Oxygen Therapy: a Randomized Control Trial
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.
Read the 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.
- Being tested
- Home Oxygen Monitors
- Keywords
- Home oxygen monitors
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Oxygen MonitorsDiagnostic test
Weaning of home oxygen using information gathered from home moniotr devise
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Home Oxygen Monitors |
| 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 Receives: Diagnostic Test: Home Oxygen Monitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Wean
Length of time it takes infant to get off home oxygen
Measured: 1 -2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start8 Feb 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Why it stopped: Per PI, the team couldn't get the home oxygen monitors needed for the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frequency of Adverse Events, Health Care Utilization, Infant Growth, Parental Quality of Life, and Altitude of the Participant's HomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawn Walstrom Novak, University of New Mexico
- Investigators
- Dawn Novak, MD, Principal investigator, University of New Mexico Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492382
- Sponsor's protocol ID
- 24-105:Home Oxygen Monitors
- Status last verified
- Mar 2025
- First submitted
- 1 Jul 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Home Monitors Used with Home Oxygen Therapy: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06492382
- Acronym / sponsor ID
- 24-105:Home Oxygen Monitors
- Keywords
- Home oxygen monitors
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Per PI, the team couldn't get the home oxygen monitors needed for the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 8 Feb 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home oxygen monitor | Experimental | Diagnostic Test: Home Oxygen MonitorsInfant 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 | Diagnostic Test: Home Oxygen MonitorsInfant will have a home oxygen weaning guideline for their pediatrician to use based on parameters other than a home oxygen monitor |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- • Infants being discharged with home oxygen therapy.
Key exclusion criteria (7 listed)
- • 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Oxygen MonitorsWeaning of home oxygen using information gathered from home moniotr devise | Diagnostic test | Home oxygen monitor, No Home oxygen monitor |
Primary outcome
Oxygen Wean
Time frame: 1 -2 months
Length of time it takes infant to get off home oxygen
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Novak, MD principal investigator
University of New Mexico Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Home Oxygen Monitors in people with Frequency of Adverse Events, Health Care Utilization, Infant Growth, Parental Quality of Life, and Altitude of the Participant's Home, run by University of New Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen Wean (time frame: 1 -2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.