Mic-Key Versus Mini One Family Preference Comparison

Gastroesophageal Reflux Clinical Trial

— MicKeyVMini  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03041649
• Other study ID #: 16070489
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Family Satisfaction
• Feeding and Eating Disorders
• Feeding Disorder
• Gastroesophageal Reflux

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