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CHAMP App Feeding Difficulties Repository

CHAMP App Feeding Difficulties Repository

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06129877
Enrollment
1000
Registered
2023-11-13
Start date
2023-11-09
Completion date
2028-12-31
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

mHealth, Software Platform, asynchronous remote monitoring

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.

Detailed description

Around 25% of children are reported to have some degree of feeding issues of whom 3-10% have more severe feeding disorders1. Many of these feeding issues and difficulties can also lead to a need for supplemental nutrition in a child's diet due to the impact on growth. Those requiring supplemental nutrition may find themselves having to be fed using tube feedings (TF), which carries its own set of obstacles and factors to consider. While feeding problems have been estimated to occur in 25%-35% of children observed as exhibiting normal growth, that number may spike to 85% in those with GI-related growth disorders2. This highlights the need to ensure treatment plans and programs are in place to assist this patient population. At Children's Mercy Hospital, GI specialists care for children who have a variety of conditions, caring for the whole child and addressing physical, mental, emotional, and social aspects. By using a combined approach, and promoting research that seeks to improve care, significant improvements in children's health have been reported. One specialty this has been evident in at Children's Mercy is the cardiac patient population. There have been improvements in growth, feedings, and timeliness of interventions seen with the use of CHAMP® App in the single ventricle population (a statistically significant difference in the frequency of growth failure, with no patients having growth failure during CHAMP use)3-4. By harnessing the experience and knowledge gained through the CHAMP® App research study, there is a great potential for children suffering from GI conditions to also benefit from this form of remote patient management and monitoring, especially when it comes to treating children with supplemental nutrition needs. There are no known Gastroenterology- Feeding mobile health software platforms with a dedicated research repository in pediatrics.

Interventions

DEVICECHAMP App

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

Sponsors

Children's Mercy Hospital Kansas City
Lead SponsorOTHER
The Gerber Foundation
CollaboratorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Feeding difficulty management12 monthsPercent of patients eating all calories by mouth at the end of asynchronous remote monitoring period for feeding management

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLori Erickson, PhD

Director, Remote Health Solutions Children's Mercy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026