What is this study trying to find out about children with feeding tubes and tracheostomies?

This study is evaluating whether a combined in-home and virtual therapy program can help children with feeding tubes and tracheostomies increase their ability to feed orally. The research aims to see if this coordinated approach improves feeding outcomes and caregiver confidence. The University of Chicago is leading this effort to develop better support for these children.

Who may be eligible for this feeding tube and tracheostomy clinical trial?

Children under 3 years old who live at home, have a gastrostomy feeding tube and a tracheostomy, and live within 1 hour of the University of Chicago or can travel there may be eligible. Participation also requires parental consent and availability for study visits. Please review eligibility criteria for more details.

Is there any cost to participate in this feeding tube clinical trial?

Study-related care, including virtual therapy sessions and all trial visits, is provided at no cost. Personal expenses such as travel or accommodations may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase Not Applicable

Age: 0 - 3Years

All Genders

ID06525818

Support Program for Children Under 3 Years With Feeding Tubes and Tracheostomies Combining Virtual and In-Home Therapies to Increase Oral Feeding

Led by University of Chicago · Updated on 2026-07-10

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying children under 3 years old who have feeding tubes and tracheostomies to test a new intervention aimed at supporting their transition to oral feeding. This study evaluates whether a combined approach using in-home clinical assessments and virtual therapy can help these children increase oral feeding compared to a control group. The intervention involves a coordinated feeding team including occupational therapists, speechlanguage pathologists, dietitians, and a developmental behavioral pediatrician. Participants are divided into two groups an intervention group and a control group. The intervention group receives weekly virtual group mealtime sessions and individual virtual therapy sessions at least every two weeks tailored to their needs. The control group joins weekly virtual group mealtime sessions only. Both groups continue any existing therapies and are assessed regularly. The study includes an initial home enrollment visit, multiple virtual assessments, and a final exit home visit at 1 year. During the study, parents participate in video conferencing for consent and enrollment, complete surveys, and engage in virtual therapy sessions. The team conducts feeding assessments using standardized surveys and dietary histories at enrollment and at 3, 6, 9, and 12 months. Researchers monitor changes in oral calorie intake, feeding frequency, and caregiver confidence. The study lasts one year per participant, with assessments and support provided throughout.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 3Years

All Genders

Eligibility Criteria

You may qualify if you...

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.

You will not qualify if you...

Wards of the state

Research Team

Emma Lynch, MPH

Sarah Sobotka, MD, MSCP

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here