Ventilator WeaningHOMVent4KidsNCT06055413
Home-based Optimization of Mechanical Ventilation in Children
A study testing Remote patient monitoring (RPM) bundle in people with Ventilator Weaning, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
Some children who are born very early or have other congenital conditions may develop severe, long-term lung problems that make them need to use a breathing machine to live at home. There are no studies that identify the best ways to monitor a home breathing machine or adjust its settings. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Ventilator Weaning
- What is being tested?
- Remote patient monitoring (RPM) bundle
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2023to 24 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- The patient has progressive neuromuscular or other condition for which decreasing support during the day is not anticipated.
- The patient is already off of ventilation during the day while awake.
- The patient will turn 18 during participation.
- The patient has planned a transition of care to another institution or move during the planned study period after enrollment.
- The patient is in active hospice or similar end-of-life care at time of study enrollment.
- The patient is living in long-term institution, transitional facility, or not within a stable home setting during the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: Remote Monitoring to Optimize Ventilatory Support in Children With Invasive Home Mechanical Ventilation
Some children who are born very early or have other congenital conditions may develop severe, long-term lung problems that make them need to use a breathing machine to live at home. There are no studies that identify the best ways to monitor a home breathing machine or adjust its settings. Increasingly, healthcare systems are using information collected at home to make more informed decisions about a patient's healthcare treatment, which is called "remote patient monitoring". This study will ask whether using remote patient monitoring can provide more complete information to a child's team of doctors, nurses, and respiratory therapists to help a child's healthcare team and family make more informed decisions about a child's home ventilator care. The investigators are hypothesizing it can safely decrease the level of breathing support children need while also avoiding emergency and hospital care and supporting their growth, development, and participation in daily life.
Read the detailed description
This is a single-arm, non-randomized, open-label trial using remote patient monitoring for chronic management of invasive home mechanical ventilation in children. The investigators hypothesize that integration of longitudinal physiologic data and patient reported outcome measures into routine clinical care over 4 months can optimize home mechanical ventilation use by 1) reducing the level home mechanical ventilation level of support, 2) improving patient and family quality of life, specifically participation in daily activities and patient's lung symptoms, and 3) improving family-reported shared decision-making and child's access to ventilator care. The investigators will also evaluate its usability within family life and provider workflows and assess early implementation outcomes.
- Conditions
- Ventilator Weaning
- Being tested
- Remote patient monitoring (RPM) bundle
- Keywords
- Children with medical complexity, Home mechanical ventilation, Long-term ventilation, Remote patient monitoring, Digital health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote patient monitoring (RPM) bundleOther
Patient-families will be given a "remote patient monitoring (RPM) bundle" with tools to measure objective and subjective information about the child at home that are shared with the home ventilator provider team through an electronic dashboard. The tools include a device to measure carbon dioxide, a digital tablet, a digital weight scale, and a digital application that connects to the child's electronic health record. Each child will be assigned an individualized remote monitoring schedule (timing and data type) based on their indication for ventilation and ventilator regimen at enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Patients receiving the intervention. Receives: Other: Remote patient monitoring (RPM) bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of ventilator support
Liters/kg/day
Measured: 4 months
Secondary outcomes (12)
Cessation of awake positive pressure
Percentage of patients on any positive pressure ventilation during the day (per post discharge days)
Measured: 4 months
Cessation of positive pressure
Percentage of patients on any positive pressure ventilation at any time (per post discharge days)
Measured: 4 months
Ventilator management frequency
Number of ventilator management changes made per patient
Measured: 4 months
Quality of life via participation
Two questions asking about to what extent the child's health issues interfered the child and the parent's with ability to engage in their usual activities. The questions are scored as 1, Not at all, 2, Slightly, 3, Moderately, 4, Quite a lot , 5, Extremely regarding how much the child's health affecting activity participation.
Measured: 4 months
Lung symptom control
Parent report using bronchopulmonary dysplasia survey measure
Measured: 4 months
Level of shared decision making
National Survey of Children's Health
shared decision-making survey questions
Measured: 4 months
Perceived access to ventilator care
Parent reported survey measure of their child's access to ventilator care
Measured: 4 months
Child growth
Patient height and weight (absolute and Z scores)
Measured: 4 months
Child healthcare utilization
Number of emergency department visits and hospitalizations.
Measured: 4 months
Reach
To what degree potential patient participants participated, defined by comparing how many were approached versus participated.
Measured: 4 months
Adoption
What percentage of eligible providers participated and what percentage of patients completed study.
Measured: 4 months
Implementation
What was the rate of data collection and entry were completed by parents and reviewed by providers.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start20 Sep 2023
- Primary completion24 Oct 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventilator WeaningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn Foster, Northwestern University
- Investigators
- Carolyn C Foster, MD, MS, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055413
- Sponsor's protocol ID
- 2020-3600
- Acronym
- HOMVent4Kids
- Status last verified
- Oct 2025
- First submitted
- 14 Sep 2023
- Last updated
- 31 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Foster C, Noreen P, Grage J, Kwon S, Hird-McCorry LP, Janus A, Davis MM, Goodman D, Laguna T. Predictors for invasive home mechanical ventilation duration in bronchopulmonary dysplasia. Pediatr Pulmonol. 2023 Jul;58(7):2085-2093. doi: 10.1002/ppul.26437. Epub 2023 Apr 28.
PubMed 37114844Foster CC, Kwon S, Shah AV, Hodgson CA, Hird-McCorry LP, Janus A, Jedraszko AM, Swanson P, Davis MM, Goodman DM, Laguna TA. At-home end-tidal carbon dioxide measurement in children with invasive home mechanical ventilation. Pediatr Pulmonol. 2022 Nov;57(11):2735-2744. doi: 10.1002/ppul.26092. Epub 2022 Aug 24.
PubMed 35959530
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring to Optimize Ventilatory Support in Children With Invasive Home Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT06055413
- Acronym / sponsor ID
- HOMVent4Kids / 2020-3600
- Conditions
- Ventilator Weaning
- Keywords
- Children with medical complexity, Home mechanical ventilation, Long-term ventilation, Remote patient monitoring, Digital health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 24 Oct 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Some children who are born very early or have other congenital conditions may develop severe, long-term lung problems that make them need to use a breathing machine to live at home. There are no studies that identify the best ways to monitor a home breathing machine or adjust its settings. Increasingly, healthcare systems are using information collected at home to make more informed decisions about a patient's healthcare treatment, which is called "remote patient monitoring". This study will ask whether using remote patient monitoring can provide more complete information to a child's team of doctors, nurses, and respiratory therapists to help a child's healthcare team and family make more informed decisions about a child's home ventilator care. The investigators are hypothesizing it can safely decrease the level of breathing support children need while also avoiding emergency and hospital care and supporting their growth, development, and participation in daily life.
Detailed description
This is a single-arm, non-randomized, open-label trial using remote patient monitoring for chronic management of invasive home mechanical ventilation in children. The investigators hypothesize that integration of longitudinal physiologic data and patient reported outcome measures into routine clinical care over 4 months can optimize home mechanical ventilation use by 1) reducing the level home mechanical ventilation level of support, 2) improving patient and family quality of life, specifically participation in daily activities and patient's lung symptoms, and 3) improving family-reported shared decision-making and child's access to ventilator care. The investigators will also evaluate its usability within family life and provider workflows and assess early implementation outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Remote patient monitoring (RPM) bundlePatients receiving the intervention. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- The patient has progressive neuromuscular or other condition for which decreasing support during the day is not anticipated.
- The patient is already off of ventilation during the day while awake.
- The patient will turn 18 during participation.
- The patient has planned a transition of care to another institution or move during the planned study period after enrollment.
- The patient is in active hospice or similar end-of-life care at time of study enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote patient monitoring (RPM) bundlePatient-families will be given a "remote patient monitoring (RPM) bundle" with tools to measure objective and subjective information about the child at home that are shared with the home ventilator provider team through an electronic dashboard. The tools include a device to measure carbon dioxide, a digital tablet, a digital weight scale, and a digital application that connects to the child's electronic health record. Each child will be assigned an individualized remote monitoring schedule (timing and data type) based on their indication for ventilation and ventilator regimen at enrollment. | Other | Intervention Arm |
Primary outcome
Level of ventilator support
Time frame: 4 months
Liters/kg/day
12 secondary outcomes
Cessation of awake positive pressure
Time frame: 4 months
Cessation of positive pressure
Time frame: 4 months
Ventilator management frequency
Time frame: 4 months
Quality of life via participation
Time frame: 4 months
Lung symptom control
Time frame: 4 months
Level of shared decision making
Time frame: 4 months
Perceived access to ventilator care
Time frame: 4 months
Child growth
Time frame: 4 months
Child healthcare utilization
Time frame: 4 months
Reach
Time frame: 4 months
Adoption
Time frame: 4 months
Implementation
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
- Background: PubMed 37114844Foster C, Noreen P, Grage J, Kwon S, Hird-McCorry LP, Janus A, Davis MM, Goodman D, Laguna T. Predictors for invasive home mechanical ventilation duration in bronchopulmonary dysplasia. Pediatr Pulmonol. 2023 Jul;58(7):2085-2093. doi: 10.1002/ppul.26437. Epub 2023 Apr 28.
- Background: PubMed 35959530Foster CC, Kwon S, Shah AV, Hodgson CA, Hird-McCorry LP, Janus A, Jedraszko AM, Swanson P, Davis MM, Goodman DM, Laguna TA. At-home end-tidal carbon dioxide measurement in children with invasive home mechanical ventilation. Pediatr Pulmonol. 2022 Nov;57(11):2735-2744. doi: 10.1002/ppul.26092. Epub 2022 Aug 24.
- Foster Health LabLink provided by the sponsor.
- Primary InvestigatorLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn C Foster, MD, MS principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote patient monitoring (RPM) bundle in people with Ventilator Weaning, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of ventilator support (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06055413, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025; AzTrials last refreshed its copy on 31 Oct 2026.