Family Satisfaction, Feeding Disorder, Gastroesophageal Reflux
Conditions
Keywords
Gastroesophageal Reflux, Feeding Disorder, Gastrostomy tube, Family Satisfaction, GT button, Enteral nutrition, Gastrostomy button
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.
Interventions
OTHERGT button change - Mini One
After 2 months with each button, parents will be asked which button they prefer at the 4-month post-operational follow-up visit.
OTHERGT button change - Mic-Key
After 2 months with each button, parents will be asked which button they prefer at the 4-month post-operational follow-up visit.
Sponsors
Children's Mercy Hospital Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parent preference | 4 months | Parents will be asked which button they prefer to keep at the 4-month visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Enteral Access Assessment Sheet | Up to 4 years after button placement | 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. |
Countries
United States
Outcome results
None listed