NCT06492382

The Effects of Home Monitors Used with Home Oxygen Therapy

The Effects of Home Monitors Used with Home Oxygen Therapy: a Randomized Control Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Home Oxygen Monitors	Weaning of home oxygen using information gathered from home moniotr devise

Timeline

• Start date: 2025-02-08
• Primary completion: 2025-06-01
• Completion: 2026-03-01
• First posted: 2024-07-09
• Last updated: 2025-03-11