The Effects of Home Monitors Used with Home Oxygen Therapy

University of New Mexico (UNM)

Status: Withdrawn

Conditions: Frequency of Adverse Events, Health Care Utilization, Infant Growth, Parental Quality of Life, and Altitude of the Participant's Home

Treatments: Diagnostic Test: Home Oxygen Monitors

Study type: Interventional

Funder types: Other

Identifiers

NCT06492382

24-105:Home Oxygen Monitors

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Home oxygen monitor

Experimental group

Description:

Infant will be on a home oxygen weaning guideline for their pediatrician to used based on information form the home oxygen monitor

Treatment:

Diagnostic Test: Home Oxygen Monitors

No Home oxygen monitor

Active Comparator group

Description:

Infant will have a home oxygen weaning guideline for their pediatrician to use based on parameters other than a home oxygen monitor

Treatment:

Diagnostic Test: Home Oxygen Monitors