Clinical trial NCT06492382: The Effects of Home Monitors Used with Home Oxygen Therapy
Official title: The Effects of Home Monitors Used with Home Oxygen Therapy: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Frequency of Adverse Events, Health Care Utilization, Infant Growth, Parental Quality of Life, and Altitude of the Participant's Home
Keywords: Home oxygen monitors
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study\&#39;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\&#39;s home.

Exploratory Aim 1: Determine the perceptions of families regarding home monitor use.

Eligibility criteria: 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.

Primary outcomes:
measure: Oxygen Wean
timeFrame: 1 -2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of New Mexico Children&#39;s Hospital
name: Dawn Novak, MD
role: PRINCIPAL_INVESTIGATOR
References: