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临床试验/NCT06129877
NCT06129877Enrolling By Invitation不适用

CHAMP App Feeding Difficulties Repository

Children's Mercy Hospital Kansas City2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年11月9日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
1,000
试验地点
2
主要终点
Feeding difficulty management

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Feeding difficulty management

时间窗: 12 months

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

次要结局

未报告次要终点

研究者

发起方
Children's Mercy Hospital Kansas City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lori Erickson

Principal Investigator

Children's Mercy Hospital Kansas City

研究点 (2)

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