NCT03041649

Mic-Key Versus Mini One Family Preference Comparison

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: All
• Age: 1 Day – 5 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Gastroesophageal Reflux
• Feeding Disorder
• Family Satisfaction

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2016-11-01
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2017-02-03
• Last updated: 2021-10-21

Locations

1 site across 1 country: United States