Clinical trial NCT03041649: Mic-Key Versus Mini One Family Preference Comparison
Official title: Mic-Key Versus Mini: A Prospective, Randomized Trial for Family Preference Comparing Low Profile Balloon Gastrostomy Buttons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux
Feeding Disorder
Family Satisfaction
Keywords: Gastroesophageal Reflux
Feeding Disorder
Gastrostomy tube
Family Satisfaction
GT button
Enteral nutrition
Gastrostomy button
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 158
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Parent preference
timeFrame: 4 months
Secondary outcomes:
measure: Enteral Access Assessment Sheet
timeFrame: Up to 4 years after button placement
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Kansas City
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Shawn D St. Peter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdelhadi RA, Dekonenko C, Dorman RM, Oyetunji TA, St Peter SD. A Prospective, Randomized Cross-over Trial of 2 Low-profile Gastrostomy Buttons to Determine Family Preference. J Pediatr Gastroenterol Nutr. 2020 Mar;70(3):386-388. doi: 10.1097/MPG.0000000000002585.