Mic-Key Versus Mini One Family Preference Comparison

Completed · Not applicable

Conditions studied: Gastroesophageal Reflux, Feeding Disorder, Family Satisfaction

In brief

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).

Key facts

Study ID

NCT03041649

Run by

Children's Mercy Hospital Kansas City

People needed

158

Starts

2016-11-01

Expected to finish

2020-04-01

Last updated by the study team

2021-10-21

Who can join

Age: 0 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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