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NCT06525818 · ClinicalTrials.gov registry record · NA
Let's E.A.T.! (Eating With Assistive Technology): An Intervention to Support Children With Feeding Tubes and Tracheostomies
A NA study of Tracheostomy and Children With Medical Complexity, sponsored by University of Chicago.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06525818: Recruiting NA study of Tracheostomy and Children With Medical Complexity, sponsored by University of Chicago.
NCT06525818 is a NA study of Tracheostomy and Children With Medical Complexity that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 40 participants, above the 33-participant average among 3 other Tracheostomy trials with a reported enrollment target (21% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06525818, a NA study of Tracheostomy and Children With Medical Complexity, is actively recruiting participants, sponsored by University of Chicago.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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 wel
Primary Outcome
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).
Conditions Studied
Interventions
- OTHER Tube weaning therapy intervention
- OTHER Feeding Group
Study Locations (1)
Illinois
- University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-07-08 |
| Est. Completion | 2027-07-07 |
| Phase | NA |
What NCT06525818 shows while recruiting
NCT06525818 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, above the 33-participant average among 3 other Tracheostomy trials with a reported enrollment target (21% higher).
The record links to 4 conditions, with Tracheostomy appearing as the primary indexed condition, and to 2 interventions - of which Tube weaning therapy intervention is the first listed.
NCT06525818 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06525818 about?
NCT06525818 is a clinical study titled "Let's E.A.T.! (Eating With Assistive Technology): An Intervention to Support Children With Feeding Tubes and Tracheostomies". 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 exp...
What is the current status of trial NCT06525818?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2024-07-08. Estimated completion is 2027-07-07.
What conditions does trial NCT06525818 study?
This clinical trial studies the following conditions: Tracheostomy, Children With Medical Complexity, Feeding Tube, Feeding Disorder, Infancy or Early Childhood.
What interventions are being tested in trial NCT06525818?
The interventions under investigation include: Tube weaning therapy intervention (OTHER), Feeding Group (OTHER).
Who is sponsoring clinical trial NCT06525818?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06525818 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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