Home-based Optimization of Mechanical Ventilation in Children (NCT06055413) | Clinical Trial Compass
CompletedNot Applicable
Home-based Optimization of Mechanical Ventilation in Children
United States50 participantsStarted 2023-09-20
Plain-language 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. 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.
Who can participate
Age range
17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Family-Patient Inclusion criteria
* The patient uses invasive mechanical ventilation at home during any portion of the day at time of enrollment.
* The patient is 0 to 17 years old.
* The patient has at least one family caregiver (parent or other self-identified legal guardian) trained on home ventilator use who is willing to participate.
* The primary parental participant reads and speaks either English or Spanish.
Exclusion criteria
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Level of ventilator support
Timeframe: 4 months
Trial details
NCT IDNCT06055413
SponsorAnn & Robert H Lurie Children's Hospital of Chicago