Gastroesophageal Reflux Clinical Trial
— MicKeyVMiniOfficial title:
Mic-Key Versus Mini: A Prospective, Randomized Trial for Family Preference Comparing Low Profile Balloon Gastrostomy Buttons
NCT number | NCT03041649 |
Other study ID # | 16070489 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | April 2020 |
Verified date | October 2021 |
Source | Children's Mercy Hospital Kansas City |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Mercy Kansas City | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
Children's Mercy Hospital Kansas City |
United States,
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 |
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