The Effects of Home Monitors Used with Home Oxygen Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-08

Study Completion Date

2026-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Agreement Between Oxygen Saturation Measured by Two Probes in Infants on the Neonatal Unit

NCT05065229

Neonatal Disease

COMPLETED NA

Oxygen for Intrauterine Resuscitation of Category II Fetal Heart Tracings

NCT02741284

Electronic Fetal Monitoring Fetal Hypoxia Fetal-Placental Circulation

COMPLETED NA

Does Higher (100% Oxygen) Versus Lower (21% Oxygen) During CC+SI During CPR of Asphyxiated Newborns Improve Time to ROSC

NCT03902652

Heart; Arrest, Newborn Birth Asphyxia Bradycardia Neonatal

WITHDRAWN NA

SpO2 Accuracy In Vivo Testing for Neonates & Infants

NCT03843489

Pulse Oximetry

WITHDRAWN NA

Verification of Pulse Oximetry in Neonatal Population

NCT00751439

Respiratory Distress Syndrome

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Home Oxygen Monitors

Intervention Type DIAGNOSTIC_TEST

Weaning of home oxygen using information gathered from home moniotr devise

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

Group Type ACTIVE_COMPARATOR

Home Oxygen Monitors

Intervention Type DIAGNOSTIC_TEST

Weaning of home oxygen using information gathered from home moniotr devise

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Home Oxygen Monitors

Weaning of home oxygen using information gathered from home moniotr devise

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No