CHAMP For the Feeder: Tube Feeding Study

NCT06052891 | Enrolling By Invitation FDA Device

• 1 other identifier: STUDY00002775CMH
• Study Type: observational
• Target: 245
• Locations: 1 country
• Sites: 1

Brief Summary

Single site evidence-based implementation of a mHealth application for remote patient monitoring for pediatric patients ready to wean from tube feedings (TFs). The primary objective of this study is to evaluate the CHAMP® ("CHAMP App") software platforms' expansion into TF weaning through Children's Mercy (CM) Kansas City's interdisciplinary feeding team (IDC). The investigators will use the current standard of care rates of tube weaning success, time to weaning, and healthcare team communication to evaluate the change after the implementation of the evidence-based CHAMP App. For equipoise of access, the study team will provide access in this pre-post design for parent/legally authorized representative (LAR)- child family access and use the CHAMP App software platform as soon as possible.

Conditions

Feeding Disorders

Keywords

Pediatric; Feeding difficulties; Tube weaning

Outcome Measures

Primary Outcomes (5)

• Adherence Initiation

  The study team will track parent use of the CHAMP App through tracking data on 1) app initiation the time of First data sent to the healthcare team.

  Time in days, one event- the first day of data transfer of CHAMP App data after enrollment

• Adherence Implementation

  The study team will track parent use of the CHAMP App through tracking data on implementation, the amount and type (feeding volumes, type, concentration, food amount, types (formula), and weights in kg) of asynchronous remote patient monitoring data received at the recommended intervals each week

  From enrollment to study endpoint, an average of 6 weeks

• Adherence Discontinuation

  The study team will track parent use of the CHAMP App through tracking data discontinuation at the time of last data sent to the healthcare team prior to completion of study activities.

  From enrollment to study endpoint, an average of 6 weeks

• Success rate to tube weaning

  Determine how the use of a remote patient monitoring mHealth software platform impacts the success rate (%) compared with those using only a standard outpatient interdisciplinary feeding tube using a tube weaning algorithm.

  From enrollment to study endpoint, an average of 6 weeks

• Time to weaning

  Determine how the use of a remote patient monitoring mHealth software platform the time (weeks) for children that were able to get 100% of calories by mouth while maintaining age-appropriate growth, compared with those using only a standard outpatient interdisciplinary feeding tube using a tube weaning algorithm.

  From enrollment to study endpoint, an average of 4 weeks

Interventions

CHAMP Application DEVICE

Children's Mercy Kansas City's CHAMP application was developed for data transfer of pediatric cardiac population vitals from home to the healthcare team in March 2014. CHAMP provides families and the clinical team with a new model of care leveraged by a remote patient monitoring (RPM) platform. CHAMP has been used in over 1000 patients, 28 states, and across 12 pediatric hospitals in pediatric cardiology. The CHAMP application is available in 11 languages for families to use on mobile devices (Apple and Android).

Eligibility Criteria

• Age: 1 Month - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients in the Interdisciplinary Feeding Clinic (IDC) patient population that are deemed ready to begin weaning from tube feeds.

You may qualify if:

• The child is between the ages of 1 month and five years 11 months.
• Child is approved for a trial of tube weaning by the managing providers of their feeding difficulty.

You may not qualify if:

• Children who do not meet the criteria to begin tube weaning.
• Children who are older than 6 years of age at time of enrollment.
• Parent/LAR of parent/LAR-child dyad who do not speak one of the languages offered via the CHAMP application (English, Spanish, German, Chinese, Vietnamese, Arabic, Korean, French, Filipino, Burmese or Somali).

Sponsors & Collaborators

• Lori Erickson: lead
• The Gerber Foundation: collaborator
• Children's Mercy Hospital Kansas City: collaborator

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Links

• Children's Mercy CHAMP Web Page

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Lori Erickson, PhD

  Children's Mercy Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Remote Health Solutions

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 25, 2023
• Study Start: November 9, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)