Assistive Technology for Children on Tube Feeding
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of this treatment for children on tube feeding?
Research shows that after tube weaning treatments, 67-69% of children were fully weaned and consumed more calories orally. This suggests that current interventions, which often include behavioral approaches and a multidisciplinary team, are generally effective in helping children transition from tube to oral feeding.12345
Is assistive technology for children on tube feeding generally safe?
The research suggests that interventions for transitioning children from tube feeding to oral feeding are generally safe, focusing on behavioral and multidisciplinary approaches. These methods aim to improve oral intake and reduce tube dependency, with no significant safety concerns reported in the studies.13456
How is tube weaning therapy different from other treatments for children on tube feeding?
Tube weaning therapy is unique because it focuses on transitioning children from tube feeding to oral feeding through a multidisciplinary approach that includes behavioral interventions, oral motor therapy, and nutritional adjustments. Unlike other treatments, it may also involve hunger-inducing methods to encourage oral intake, which are not commonly used in standard feeding therapies.23678
What is the purpose of this trial?
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.
Research Team
Sarah Sobotka, MD, MSCP
Principal Investigator
University of Chicago
Eligibility Criteria
This trial is for children with feeding tubes and tracheostomies who need help transitioning to oral feeding. It's designed for those who could benefit from an interdisciplinary approach involving in-home assessments and virtual therapies by a team of specialists.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Initial Assessment
In-home enrollment visit with comprehensive feeding assessment by interdisciplinary team
Intervention
Weekly virtual group therapy mealtime sessions and biweekly individual virtual therapies for intervention group
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Feeding Group
- Tube weaning therapy intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor
The Gerber Foundation
Collaborator