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Prospective randomized comparative study of low-profile balloon gastrostomy tubes in children
Dina Al-Zubeidi1, Riad M Rahhal
1University of Iowa, Iowa City, IA 52241, USA.
Insights
This study compared two low-profile balloon gastrostomy tubes in children. Both tubes demonstrated comparable performance regarding caregiver satisfaction and complication rates, indicating suitability for pediatric enteral nutrition.
Area of Science:
- Pediatric Gastroenterology
- Medical Device Technology
Background:
- Enteral nutrition via gastrostomy tubes is common in children.
- Limited prospective data exists comparing different low-profile balloon gastrostomy tube types in pediatric populations.
Purpose of the Study:
- To prospectively compare the performance of two low-profile balloon gastrostomy tubes in children.
- Evaluate caregiver satisfaction, tube-related complications, and device durability.
Main Methods:
- A crossover study design was employed with 21 pediatric patients.
- Patients used two types of low-profile balloon gastrostomy tubes (Tube A and Tube B) for 4-month periods each.
- Outcomes assessed included infection rates, leakage, granulation tissue, caregiver satisfaction, and device durability.
Main Results:
- Infection and overall leakage rates were similar between Tube A and Tube B.
- Tube B showed a trend towards lower formula leakage and granulation tissue.
- Tube A demonstrated a trend towards better device durability, while Tube B had higher caregiver satisfaction scores.
Conclusions:
- Both low-profile balloon gastrostomy tubes evaluated performed comparably in the pediatric population.
- Caregiver satisfaction, complication rates, and overall device durability were similar between the two tube types.
Background:
Supplemental enteral nutrition through gastrostomy tubes is well established in children, but prospective studies comparing different tubes remain lacking in this population. The study aimed at comparing different aspects related to the use of low-profile balloon gastrostomy tubes in children.
Materials And Methods:
The authors prospectively studied the use of 2 tube types--tube A (MIC-Key gastrostomy tube; Ballard Medical Products, Draper, UT) and tube B (MINI One gastrostomy tube; Applied Medical Technology, Brecksville, OH)--in a cohort of children in a crossover study design. Children were randomly assigned to 1 tube type for 4 months, followed by the other tube type for the next 4 months. Patients were evaluated at enrollment and at 4 and 8 months, with monitoring phone calls at 2 and 6 months. Variables measured included caregiver satisfaction, tube-related complications, and device durability.
Results:
Twenty-one patients were included in the study. Infection rate (range, 4.8%-5.0%) and overall leakage rate (range, 42.9%-50.0%) were similar in both groups. Trends were noted with other variables measured but without statistical significance. These included lower rates of formula leakage and granulation tissue growth and higher satisfaction scores with tube B and more favorable device durability with tube A.
Conclusion:
Both low-profile balloon gastrostomy tubes performed well and had comparable caregiver satisfaction, complications, and overall device durability.
