Mic-Key Versus Mini One Family Preference Comparison (MicKeyVMini)

October 19, 2021 updated by: Children's Mercy Hospital Kansas City

Mic-Key Versus Mini: A Prospective, Randomized Trial for Family Preference Comparing Low Profile Balloon Gastrostomy Buttons

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Kansas City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GT button change - Mic-Key
Subjects randomized to the Mic-Key arm will have the Mic-Key button placed initially at surgery, and at the first gastrostomy change in the clinic at 2 months, will change to the Mini One button. At the routine 4-month visit, parents will be asked which button they prefer to keep.
Other: 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.
Active Comparator: GT button change - Mini One
Subjects randomized to the Mini One arm will have the Mini One button placed initially at surgery, and at the first gastrostomy change in the clinic at 2 months, will change to the Mic-Key button. At the routine 4-month visit, parents will be asked which button they prefer to keep.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent preference
Time Frame: 4 months
Parents will be asked which button they prefer to keep at the 4-month visit.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enteral Access Assessment Sheet
Time Frame: Up to 4 years after button placement
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

January 9, 2017

First Submitted That Met QC Criteria

February 1, 2017

First Posted (Estimate)

February 3, 2017

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 19, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16070489

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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