The Effects of Home Monitors Used with Home Oxygen Therapy

March 6, 2025 updated by: Dawn Walstrom Novak, University of New Mexico

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Diagnostic test: Home Oxygen Monitors
Weaning of home oxygen using information gathered from home moniotr devise
Active Comparator: 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
Diagnostic test: Home Oxygen Monitors
Weaning of home oxygen using information gathered from home moniotr devise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen Wean
Time Frame: 1 -2 months
Length of time it takes infant to get off home oxygen
1 -2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Investigators

  • Principal Investigator: Dawn Novak, MD, University of New Mexico Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 8, 2025

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

July 1, 2024

First Submitted That Met QC Criteria

July 1, 2024

First Posted (Actual)

July 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24-105:Home Oxygen Monitors

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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