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

Children's Mercy Hospital Kansas City

Status: Completed

Conditions: Family Satisfaction; Gastroesophageal Reflux; Feeding Disorder

Treatments: Other: GT button change - Mini One; Other: GT button change - Mic-Key

Study type: Interventional

Funder types: Other

Identifiers

NCT03041649

16070489

Details and patient eligibility

About

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).

Full 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.

Enrollment: 158 patients

Sex: All

Ages: 1 day to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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158 participants in 2 patient groups

GT button change - Mic-Key

Active Comparator group

Description:

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.

Treatment:

Other: GT button change - Mini One

GT button change - Mini One

Active Comparator group

Description:

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.

Treatment:

Other: GT button change - Mic-Key