Enteral Feeding, Enteral Nutrition, Gastrostomy Tube
Conditions
Keywords
gastrostomy, enteral
Brief summary
The purpose of this study is to determine the best way to feed children after they have a gastrostomy tube placed. The study compares bolus feeding to continuous feeding.
Detailed description
This study will consist of a prospective, randomized comparison of bolus versus continuous enteral feeding protocols in pediatric patients with gastrostomy tubes
Interventions
PROCEDUREBolus feeding schedule following gastrostomy tube placement
PROCEDUREContinuous chimney feeds following gastrostomy tube placement
Sponsors
Children's Mercy Hospital Kansas City
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
* Less than 18 years of age * Admitted for gastrostomy tube placement, with or without Nissen Fundoplication
Exclusion criteria
* Immunocompromised patients * Short Bowel Syndrome (SBS)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of gastrostomy tube leakage | 8 weeks | Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retching | 8 weeks | Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks. |
| Venting beyond recommendations | 8 weeks | Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks. |
| Feeding changes | 8 weeks | Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks. |
| Emesis | 8 weeks | Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks. |
| G-tube infection | 8 weeks | Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks. |
| Weight | 8 weeks | Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks. |
| Time to goal feeds | 8 weeks | Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks. |
| Unscheduled clinic/ER visits/calls | 8 weeks | Symptoms are rated by parents on a daily diary for the first 4 weeks following g-tube placement, and then on a weekly diary for the next 4 weeks. |
Countries
United States
Outcome results
None listed