Mic-Key Versus Mini One Family Preference Comparison
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any - 5 |
| Updated: | 1/12/2019 |
| Start Date: | November 2016 |
| End Date: | November 2025 |
Mic-Key Versus Mini: A Prospective, Randomized Trial for Family Preference Comparing Low Profile Balloon Gastrostomy Buttons
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).
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).
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.
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.
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
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