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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03041649
Other study ID # 16070489
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date April 2020

Study information

Verified date October 2021
Source Children's Mercy Hospital Kansas City
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to compare two low profile balloon gastrostomy button enteral feeding devices, both currently used as standard of medical care. The investigators aim to compare family preference and rate of complications between the two devices in a prospective cohort of children. This is the first step in comparing initial and long-term outcomes along with the need for seeking medical advice for gastrostomy site-related complications. The secondary aim of this study is to follow this population long term (4 years) to document the prevalence of: granulation tissue, infection, skin breakdown, and how long the gastrostomy tube balloon remains functional (does not lose water).


Description:

This is a single center prospective, randomized study with a crossover design, comparing two low profile balloon gastrostomy buttons (Figure 1), MIC-Key™ and MINI One™ that are routinely used at CMH. Each subject will be randomly assigned to one button type at the time of initial placement. After placement, standard practice is to perform the first gastrostomy change in the clinic at 2 months where the primary caregivers replace the button under supervision. Therefore, the initial device after randomization will remain in place for 2 months. At the first scheduled device change, the other type of button will replace the original gastrostomy button device. This will remain in place for another 2 months. At the routine visit at 4 months the parents will be asked to choose which button they prefer to keep. This will meet the primary outcome endpoint of the study. The investigators will continue to follow as many subjects as possible to 4 years in order to identify any potential differences in secondary end points. A caregiver satisfaction survey is routinely used in the clinics. Parent responses to this survey will be also be used in the study analysis.


Recruitment information / eligibility

Status Completed
Enrollment 158
Est. completion date April 2020
Est. primary completion date April 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 5 Years
Eligibility Inclusion Criteria: - Children ages 0-5 years of age requiring 0.8 cm or 1.0 cm gastrostomy feeding devices for enteral nutrition seen in the Surgery, GI or Special Care clinics - Gastrostomy placement after IRB approval (enrollment will continue until 170 evaluable subjects have completed the 4 month visit. Expected attrition for the 4 year follow-up is 40%. - English-speaking families Exclusion Criteria: - Children with dermatologic conditions influencing gastrostomy site healing and tract epithelialization - Children with immunosuppression - Children with active malignancy requiring treatment - Inability to commit to 4 months follow up

Study Design


Intervention

Other:
GT button change - Mic-Key
After 2 months with each button, parents will be asked which button they prefer at the 4-month post-operational follow-up visit.
GT button change - Mini One
After 2 months with each button, parents will be asked which button they prefer at the 4-month post-operational follow-up visit.

Locations

Country Name City State
United States Children's Mercy Kansas City Kansas City Missouri

Sponsors (1)

Lead Sponsor Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Parent preference Parents will be asked which button they prefer to keep at the 4-month visit. 4 months
Secondary Enteral Access Assessment Sheet Providers will complete a brief checklist of gastrostomy tube maintenance and site complications at the 2-month button change, 4-month visit, and all subsequent follow-up visits while the button while the G-tube remains in place. Up to 4 years after button placement
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