CHAMP App Feeding Difficulties Repository

NCT06129877 | Enrolling By Invitation FDA Device

• 1 other identifier: STUDY00002753
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This repository will consist of home monitoring data, videos, and images of patients with feeding difficulties for asynchronous remote patient monitoring of manually entered data sent by parents to the healthcare team using the CHAMP App for children with feeding difficulties. This information will be collected under a research protocol and this repository is for future research applications.

Conditions

Feeding and Eating Disorders of Childhood; Gastrostomy; Feeding Disorder of Infancy and Childhood

Keywords

mHealth; Software Platform; asynchronous remote monitoring

Outcome Measures

Primary Outcomes (1)

• Feeding difficulty management

  Percent of patients eating all calories by mouth at the end of asynchronous remote monitoring period for feeding management

  12 months

Interventions

CHAMP App DEVICE

CHAMP App software platform will have been used in other research studies to be included in the Feeding difficulties repository

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with feeding difficulties and/or malnutrition

You may qualify if:

• Patients enrolling in this research repository must also be enrolled in an applicable study (STUDY00002775, STUDY00003221) wherein they have consented to use CHAMP App
• Parent-Legally authorized representative can read one of the eleven languages that the CHAMP App is available in.

You may not qualify if:

• All patients and parents/Legally authorized representative not meeting the above specified criteria

Sponsors & Collaborators

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

Study Sites (1)

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders of Childhood

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Lori Erickson, PhD

  Director, Remote Health Solutions Children's Mercy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 13, 2023
• Study Start: November 9, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

US (1)