Bolus Versus Continuous Feeding Regimens Post Gastrostomy Tube Placement

Study Overview
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Brief Summary
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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
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This study will consist of a prospective, randomized comparison of bolus versus continuous enteral feeding protocols in pediatric patients with gastrostomy tubes

Official Title
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Bolus Versus Continuous Feeding Regimens Post Gastrostomy Tube Placement

Conditions
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Enteral Nutrition, Enteral Feeding, Gastrostomy Tube

Intervention / Treatment
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* Procedure: Bolus feeding schedule following gastrostomy tube placement
* Procedure: Continuous chimney feeds following gastrostomy tube placement


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bolus<br>Bolus: Total volume of feedings is determined by the amount of formula required to meet calorie and protein needs, which is determined by a Registered Dietitian. Volume of each bolus is determined by dividing the total volume of feeding by the desired number of feedings per day: If child is less than 6 months: 8 feeds/day If child is 6-12 months 6 feeds/day If child is 12 months or greater: 5 feedings/day Rate of feeds is determine by the rate needed to infuse each bolus over 1 hour. Patient to remain NPO. Once at goal, if able to take PO, may offer orally first with remainder of goal volume over the remainder of the hour. | Procedure: Bolus feeding schedule following gastrostomy tube placement<br> <br> |
| Active Comparator: Continuous<br>Continuous: Total volume of feedings is determined by the amount of formula required to meet calorie and protein needs, which is determined by a Registered Dietitian. Rate of feeds is determined by dividing total volume of feedings by 24 hours. Patient is to remain NPO. Once at goal, if able to take PO, may offer hourly amount orally, but only 2x per day. | Procedure: Continuous chimney feeds following gastrostomy tube placement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of gastrostomy tube leakage | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emesis | 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. | 8 weeks | 
| Retching | 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. | 8 weeks | 
| Venting beyond recommendations | 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. | 8 weeks | 
| Feeding changes | 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. | 8 weeks | 
| Unscheduled clinic/ER visits/calls | 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. | 8 weeks | 
| G-tube infection | 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. | 8 weeks | 
| Weight | 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. | 8 weeks | 
| Time to goal feeds | 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastrostomy, enteral