Assistive Technology for Children on Tube Feeding

Overseen By Emma Lynch, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Wards of the state

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

40 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

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. ^{1 2 4 5 6}

Who Is on the Research Team?

Sarah Sobotka, MD, MSCP

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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

I am under 3 years old.

Reside at a family home

Have a gastrostomy feeding tube

Exclusion Criteria

Wards of the state

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Initial Assessment

In-home enrollment visit with comprehensive feeding assessment by interdisciplinary team

1 week

1 visit (in-person)

Intervention

Weekly virtual group therapy mealtime sessions and biweekly individual virtual therapies for intervention group

12 months

Weekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Feeding Group
• Tube weaning therapy intervention

Trial Overview The study tests a hybrid intervention combining in-person and virtual support to improve oral feeding. It includes sessions with occupational therapists, speech/language pathologists, dietitians, family liaisons, and a project leader specialized in pediatric care.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 2 Interventions

All participants in the intervention group will be invited to weekly virtual group therapy mealtime sessions with the Speech-Language Pathologist and other participants in the intervention group. Additionally, families will engage in virtual therapy sessions at least biweekly focused on individualized goals informed by the expertise of the study team and published expert programs. Individualized programs will include virtual sessions with the occupational therapist, speech therapist, or combined therapies. The team will consult with the registered dietitian and Developmental and Behavioral Pediatrician as needed.

Group II: Control group Experimental Treatment 1 Intervention

All participants in the control group will be invited to a weekly virtual group therapy mealtime session with other enrolled control group participants and a speech therapist who is not involved with the intervention. During this informal session, families will have the opportunity to meet other children with feeding tubes and their parents. The investigators will assess level of engagement (frequency of participation) and parental experience at interval assessments. Therapies research participants are already receiving or who begin to receive during the study period (early intervention community therapies, center-based therapies) will not be stopped during this intervention. Data will be collected on the frequency of these standard of care therapies. The assessments used for the control group will be the same assessments as the intervention group and will include the Speech Therapy Assessment; Occupational Therapy Assessment; and Pediatric Eating Assessment Toll.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

The Gerber Foundation

Collaborator

Trials

45

Recruited

6,200+

Published Research Related to This Trial

A systematic review of 42 studies found that 67-69% of children with severe feeding issues were successfully weaned off tube feeding, indicating that current interventions are generally effective.

Post-treatment, children significantly increased their oral calorie intake, suggesting that tube weaning interventions can improve nutritional intake, although more randomized clinical trials are needed to identify the most effective treatment components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Tube Weaning: A Meta-Analysis of Factors Contributing to Success. Killian, HJ., Bakula, DM., Wallisch, A., et al.[2023]

A study involving eight feeding teams from Australia, Europe, and the USA found that a multi-model approach to tube weaning is commonly used, incorporating both sensori-motor and psychological interventions.

Most teams employed hunger induction as a strategy to initiate tube weaning, highlighting the importance of psychological theory in the treatment process, though further research is needed to evaluate the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A descriptive comparison of approaches to paediatric tube weaning across five countries. Gardiner, AY., Vuillermin, PJ., Fuller, DG.[2022]

Long-term tube feeding can lead to tube dependency in children, making it crucial to transition to oral feeding to avoid health and psychosocial issues.

A multidisciplinary approach is recommended for weaning off tube feeding, with various treatment options including behavioral interventions, oral motor therapy, and nutritional adjustments to support the transition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development, prevention, and treatment of feeding tube dependency. Krom, H., de Winter, JP., Kindermann, A.[2022]

A qualitative scoping review of tube weaning interventions in enterally fed children identified three main approaches: behavioral, child- and family-centered, and biomedical, highlighting the diversity in intervention philosophies.

The review revealed a lack of consistency in outcome measures across studies, which hampers the ability to compare the effectiveness of different weaning programs and suggests that the role of parents in the weaning process needs further exploration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing International Approaches to Weaning Children From Tube Feeding: A Scoping Review. Lively, EJ., McAllister, S., Doeltgen, SH.[2021]

Oral stimulation is the most effective intervention for helping premature infants transition from tube feeding to independent oral feeds, supported by consistent evidence from 14 studies in the review.

Other types of stimulation, such as swallow/gustatory stimulation, show some potential benefits, but there is limited evidence for olfactory, tactile/kinesthetic, and auditory stimulation, indicating a need for more research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to Enhance Achievement to Independent Oral Feeds in Premature Infants: A Scoping Review. Sheikh-Mohamed, SO., Wilson, H., Fucile, S.[2023]

Tube feeding can temporarily improve nutrition and growth in children, but transitioning to oral feeding can be challenging due to various oral-motor and sensory issues.

A four-step process involving caregiver support, assessing readiness, normalizing feeding behaviors, and implementing a behavioral feeding plan is recommended to facilitate a successful transition from tube to oral feeding, ultimately benefiting the child's long-term health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transition from tube feedings to feedings by mouth in children: preventing eating dysfunction. Schauster, H., Dwyer, J.[2015]

The study is a randomized controlled trial assessing the safety and efficacy of megestrol as part of the iKanEat protocol, which aims to help children transition from tube feeding to oral eating.

The trial will also evaluate the impact of this transition on parent stress and the quality of life for both parents and children, providing valuable insights into the broader effects of tube weaning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

iKanEat: protocol for a randomized controlled trial of megestrol as a component of a pediatric tube weaning protocol. Edwards, S., Hyman, PE., Mousa, H., et al.[2021]

Parents of tube-fed children often lack awareness about the need for tube weaning and the processes involved, highlighting a gap in communication with healthcare teams.

When parents are included as active members of the therapeutic team and provided with support and options, they are more willing to engage in the tube weaning process, which can lead to better outcomes for their child's transition to oral feeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parents' experiences of their child's transition from tube to oral feeding during an intensive intervention programme. Lively, EJ., McAllister, S., Doeltgen, SH.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Pediatric Tube Weaning: A Meta-Analysis of Factors Contributing to Success. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A descriptive comparison of approaches to paediatric tube weaning across five countries. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Development, prevention, and treatment of feeding tube dependency. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Characterizing International Approaches to Weaning Children From Tube Feeding: A Scoping Review. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Interventions to Enhance Achievement to Independent Oral Feeds in Premature Infants: A Scoping Review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Transition from tube feedings to feedings by mouth in children: preventing eating dysfunction. [2015]

7. England pubmed.ncbi.nlm.nih.gov

iKanEat: protocol for a randomized controlled trial of megestrol as a component of a pediatric tube weaning protocol. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Parents' experiences of their child's transition from tube to oral feeding during an intensive intervention programme. [2023]