NCT06129877

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Nov 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Nov 2023Dec 2028

First Submitted

Initial submission to the registry

November 3, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

November 9, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

5.1 years

First QC Date

November 3, 2023

Last Update Submit

May 1, 2026

Conditions

Feeding and Eating Disorders of ChildhoodGastrostomyFeeding Disorder of Infancy and Childhood

Keywords

mHealthSoftware Platformasynchronous 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 AppDEVICE

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

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 DisordersMental 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

May 7, 2026

Record last verified: 2026-05

Locations

US(1)