Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06129877 |
| Other study ID # |
STUDY00002753 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 9, 2023 |
| Est. completion date |
December 31, 2028 |
Study information
| Verified date |
February 2024 |
| Source |
Children's Mercy Hospital Kansas City |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
