Let's E.A.T.! (Eating With Assistive Technology): An Intervention to Support Children With Feeding Tubes and Tracheostomies
NCT Number: NCT06525818
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Feeding Tube|Children With Medical Complexity|Tracheostomy|Feeding Disorder, Infancy or Early Childhood
Interventions: OTHER: Tube weaning therapy intervention|OTHER: Feeding Group
Sponsor: University of Chicago
Collaborators: The Gerber Foundation
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-08
Completion Date: 2027-07-07
Locations: University of Chicago, Chicago, Illinois, 60637, United States

Summary:
The overall objective of this proposal is to test an interdisciplinary intervention to support the transition to oral feeding for children with feeding tubes and tracheostomies. The investigators' model which combines in-home clinical assessments with virtual therapies may maximize the impact of expert interventionists. The investigators' central hypothesis is that children with feeding tubes and tracheostomies will have greater success than a control group when enrolled in a hybrid in-person/virtual intervention including: (1) a coordinated feeding team with an occupational therapist, speech/language pathologist, and registered dietitian; (2) family liaison study coordinators who are poised to support the family through personal experience; (3) a project leader who is a Developmental Behavioral Pediatrician with expertise in children with tracheostomies. The overall objective of this proposal is to test this intervention to increase oral feeding in children with feeding tubes and tracheostomies. To pursue this objective, the investigators propose the following aims:

Specific Aim 1: Children enrolled in the intervention group will have improved caregiver self-efficacy and reduced worry related to feeding as determined by The Feeding and Swallowing Impact Survey at the end of a 1-year intervention.

Specific Aim 2: Children enrolled in the intervention group will have increased oral vs. tube-fed calories and reduced dependence on feeding tubes as determined by detailed dietary histories and The Children's Eating and Drinking Activity Scale (CEDAS) at the end of a 1-year intervention.

The investigators' intervention will determine if a tertiary center of expertise can use a combination of home assessments and virtual interventions to address critical feeding needs for children with tracheostomies. Future clinicians could refer patients to the investigators' center instead of relying on community therapists, who rarely exist.

The weekly feeding group sessions as well as the administration of the therapies in a virtual format are research-related. While the therapy techniques implemented during the study are standard of care and within the practice parameters of the practitioners involved, the use of them in a virtual format are novel and should be considered research-related.

Primary Outcome Measures: Change in percentage of oral calories, 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)., Baseline, 3 month, 6 month and exit at 1 year
Secondary Outcome Measures: Change in Oral Feeding, Change in score on the Children's Eating and Drinking Activity Scale (CEDAS) ), which describes children's dependence on tube feeding and ability to take food orally on a scale of 1-6, Baseline, 3 month, 6 month and exit at 1 year|Increased frequency of feeding trials, Increase in frequency of feeding trials throughout the day (e.g. once in the morning vs. three times each day, Baseline, 3 month, 6 month and exit at 1 year|Caregiver self-efficacy, Children enrolled in the intervention group will have improved caregiver self-efficacy and reduced worry related to feeding as determined by The Feeding and Swallowing Impact Survey which measures caregiver issues related to feeding (e.g. "I worry that my child will never eat or drink like other children) at the end of a 1-year intervention., Baseline, 3 month, 6 month and exit at 1 year