Prospective randomized comparative study of low-profile balloon gastrostomy tubes in children.

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.