A Prospective, Randomized Cross-over Trial of 2 Low-profile Gastrostomy Buttons to Determine Family Preference

Area of Science:

• Pediatric Gastroenterology
• Medical Device Technology
• Clinical Trial Design

Background:

• Low-profile gastrostomy buttons are essential for pediatric feeding.
• Comparing device performance and patient/family satisfaction is crucial for optimal care.

Purpose of the Study:

• To compare family preference between MIC-KEY (tube A) and MiniONE (tube B) gastrostomy buttons in pediatric patients.
• To evaluate gastrostomy site complications and device malfunctions associated with each button type.

Main Methods:

• A prospective, randomized crossover trial involving 158 pediatric patients.
• Patients were assigned to receive either tube A or tube B first, then switched at 2 months.
• Parental preference was assessed at 4 months, alongside standardized skin and device complication assessments.

Main Results:

• A significant majority (69%) of patients who completed the crossover preferred the MiniONE button (tube B).
• Overall, 72% of patients (91 of 127) ultimately preferred and kept the MiniONE button.
• No significant differences in skin complications or device malfunction were detailed in the provided abstract, but preference was clear.

Conclusions:

• The MiniONE gastrostomy button demonstrates a strong preference among pediatric patients' families compared to the MIC-KEY button.
• These findings suggest MiniONE may offer improved patient or caregiver satisfaction in long-term gastrostomy management.