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Let's E.A.T.! (Eating With Assistive Technology): An Intervention to Support Children With Feeding Tubes and Tracheostomies
NCT06525818 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06525818
The ClinicalTrials.gov registry entry for NCT06525818 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 846 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06525818 reports 1 study location spanning 1 distinct geographic area — top geographies include Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06525818?
The interventions under investigation include: Tube weaning therapy intervention (OTHER), Feeding Group (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06525818?
This trial is sponsored by University of Chicago, which has 846 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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