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?

This trial aims to assist young children who rely on feeding tubes and have tracheostomies (tubes in their necks to aid breathing) in transitioning to eating by mouth. It tests a combination of in-home and virtual therapies, including the Tube Weaning Therapy intervention, led by a team of specialists such as an occupational therapist, speech therapist, and dietitian. The goal is to improve feeding skills and reduce reliance on feeding tubes. Children under three years old, living at home within an hour of the University of Chicago, with both a gastrostomy tube and a tracheostomy, might be suitable candidates.

As an unphased trial, this study provides a unique opportunity to explore innovative therapies that could significantly enhance a child's quality of life.

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 prior data suggests that this intervention is safe for children with feeding tubes and tracheostomies?

Research has shown that tube weaning therapy, like the one being tested, is generally well-tolerated by children. One study found that 77.3% of children completely stopped using feeding tubes, while another 13.4% were partially weaned. These findings suggest that the therapy is effective and manageable for most participants.

Another study found that even after therapy ended, children continued to improve their eating skills and behaviors, demonstrating lasting positive effects. Additionally, a program that encouraged children to eat by inducing hunger proved very effective in helping them stop using feeding tubes, both in the short term and long term.

While these results are promising, reactions can vary. It is important to consult healthcare professionals with any concerns or questions about joining such trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the tube weaning therapy intervention for children on feeding tubes because it offers a personalized and integrative approach. Unlike standard care, which often involves isolated therapies, this method combines weekly virtual group therapy with tailored individual sessions involving speech and occupational therapists. This collaborative strategy, supported by consultations with dietitians and pediatricians, aims to address the multifaceted needs of each child. By fostering a supportive community and customizing goals, the intervention has the potential to enhance feeding skills and reduce reliance on feeding tubes more effectively than traditional methods.

What evidence suggests that this interdisciplinary intervention is effective for transitioning children with feeding tubes to oral feeding?

Research has shown that tube weaning therapy, which participants in this trial may receive, helps children transition from tube feeding to eating by mouth. Studies indicate that after this treatment, many children consume more calories through eating, with 67-69% completely stopping tube feeding. One study found that children developed good eating skills and became more successful at eating independently. This therapy can address issues related to feeding tubes, such as lack of hunger and infection risk. Overall, tube weaning therapy has shown promising results in helping children eat more naturally and safely. ^{1 4 6 7 8}

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10989027/

Pediatric Tube Weaning: A Meta-Analysis of Factors ... Results indicated that, after treatment, children received significantly more calories orally, and 67–69% of children were fully weaned.

2. research.aota.org research.aota.org/ajot/article/79/5/7905205060/27939/Impact-of-a-Responsive-Feeding-Intervention-on

Impact of a Responsive Feeding Intervention on Children and ... Results showed that the intervention effectively helped children transition to oral eating and develop positive mealtime skills and that ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jpn3.70078

Pediatric gastrostomy feeding tube weaning strategies: A ... Gastrostomy tube feeding has short-term and long-term consequences: interference with hunger regulation, potential dislodgement and infection, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0261561419332078

Long-term efficacy of clinical hunger provocation to wean ... This study shows that a 2–3 weeks lasting CHP program is highly effective to wean children below two years of age from tube feeding on short- and long-term.

5. semanticscholar.org semanticscholar.org/paper/Transitioning-children-from-tube-to-oral-feeding%3A-a-Taylor-Vir%C3%BAes%E2%80%90Ortega/5d721cc33f7d5736f840daacf9c985a1579b881e

Transitioning children from tube to oral feeding Rapid home-based weaning of small children with feeding tube dependency: positive effects on feeding behaviour without deceleration of growth · Medicine.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12376929/

Tube-Fed vs Orally-Fed Children with Early Childhood ... Children with feeding disorders may require tube feeding when oral intake is insufficient. This study compared the clinical management and parental experiences ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jpr3.12112

Long‐term implications of a multidisciplinary tube‐weaning ... Sixty-five (77.3%) out of 82 children were completely weaned from tube feeding, 11 (13.4%) were partially weaned and six (7%) were not ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06525818/lets-eat-eating-with-assistive-technology-an-intervention-to-support-children-with-feeding-tubes-and-tracheostomies?id=754&slug=ear-nose-and-throat-ent-surgeries

An Intervention to Support Children With Feeding Tubes ... The overall objective of this proposal is to test this intervention to increase oral feeding in children with feeding tubes and tracheostomies.