title: Prospective randomized comparative study of low-profile balloon gastrostomy tubes in children.
abstract: 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.
  
  
  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.
  
  
  CONCLUSIONS
  Both low-profile balloon gastrostomy tubes performed well and had comparable caregiver satisfaction, complications, and overall device durability.
authors.affiliation: University of Iowa, Iowa City, IA 52241, USA.
authors.forename: Dina
authors.initials: D
authors.lastname: Al-Zubeidi
authors.forename: Riad M
authors.initials: RM
authors.lastname: Rahhal
mesh_terms: D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D004750:Enteral Nutrition / Q000379:methods; D005260:Female; D005774:Gastrostomy / Q000295:instrumentation* / Q000379:methods*; D006801:Humans; D007223:Infant; D008297:Male; D017060:Patient Satisfaction; D011446:Prospective Studies; D011795:Surveys and Questionnaires