Clinical trial NCT06129877: CHAMP App Feeding Difficulties Repository
Official title: CHAMP App Feeding Difficulties Repository
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Feeding and Eating Disorders of Childhood
Gastrostomy
Feeding Disorder of Infancy and Childhood
Keywords: mHealth
Software Platform
asynchronous remote monitoring
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
First posted: 2023-11-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with feeding difficulties and/or malnutrition

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feeding difficulty management
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Kansas City
state: Missouri
Study officials:
affiliation: Director, Remote Health Solutions Children's Mercy
name: Lori Erickson, PhD
role: PRINCIPAL_INVESTIGATOR
References: