Let's E.A.T.! Intervention for Children with Feeding Tubes and Tracheostomies

This study, called "Let's E.A.T.!", is looking for children under 3 years old who have both a feeding tube (gastrostomy) and a tracheostomy (a breathing tube in the windpipe). The goal is to help these children transition to eating by mouth. The study is testing an intervention that combines in-home assessments with virtual therapy sessions. Some children will receive weekly virtual group mealtime sessions with a Speech-Language Pathologist and individual virtual therapy, while others will have weekly virtual group mealtime sessions with a speech therapist not involved in the main intervention. Researchers want to see if this approach helps children eat more by mouth. The study aims to enroll 40 participants and is currently unclear on its recruitment status.

Study design
This interventional study plans to enroll 40 participants. It compares two groups: one receiving a tube weaning therapy intervention and another receiving a feeding group intervention.
What's involved
You would participate in weekly virtual group therapy mealtime sessions, and potentially individual virtual therapy sessions at least biweekly. You would also need to travel to the University of Chicago for enrollment and an exit visit.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, change in percentage of oral calories, is measured at baseline, 3 months, 6 months, and at exit at 1 year.

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NCT06525818

Let's E.A.T.! (Eating With Assistive Technology): An Intervention to Support Children With Feeding Tubes and Tracheostomies

Recruiting
NAUp to 3InterventionalTreatment
University of Chicago
~40 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Tube weaning therapy interventionFeeding Group

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in percentage of oral calories
Measured over Baseline, 3 month, 6 month and exit at 1 year
Feeding Tube
Children With Medical Complexity
Tracheostomy
Feeding Disorder, Infancy or Early Childhood
1 sites across 1 states
Illinois1
  • Sarah Sobotka, MD, MSCP · PRINCIPAL_INVESTIGATOR · University of Chicago

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Eligibility criteria

Inclusion

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.
  • Change in percentage of oral caloriesBaseline, 3 month, 6 month and exit at 1 year

    Oral calories will be calculated by determining how many calories are taken by mouth as a percentage of total (gastrostomy tube plus oral calorie intake).