Virtual therapy aims to help Tube-Fed children with tracheostomies eat on their own
NCT ID NCT06525818
First seen Jul 10, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This study tests a program that combines in-home assessments with virtual therapy sessions to help children under 3 who have both a feeding tube and a tracheostomy transition to eating by mouth. The intervention includes weekly group mealtime sessions and individual therapy, led by a team of specialists. The goal is to see if this approach improves caregiver confidence and increases the amount of food children take orally over one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- virtual feeding therapy program
- What this could lead to
- If successful, this approach could help children with feeding tubes and tracheostomies learn to eat by mouth, reducing tube dependence and improving quality of life.
- What could go wrong
- This is a small, early-stage study with only 40 children. The virtual format is novel, and results may not apply to all families. Success depends on caregiver engagement and individual medical factors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 3 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Under 3 years of age * Reside at a family home * Have a gastrostomy feeding tube * Have a tracheostomy * Live within a 1-hour radius of the University of Chicago or willing to travel to the University of Chicago for enrollment and exit visit. Exclusion Criteria: • Wards of the state
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Chicago
Chicago, Illinois, 60637, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Incremental dead space versus capping trial to predict the Post-Decannulation respiratory status in tracheostomized critically ill patients: a physiological randomized crossover study
- A short lesson before a tracheostomy may calm families' fears
- Peer coaching may empower families of Ventilator-Dependent children
- Can High-Flow oxygen through a tracheostomy speed ventilator weaning?
- New tracheostomy tube holder aims to cut infections and boost comfort
- Structured nursing plan aims to cut pneumonia in stroke patients with breathing tubes