Bolus Versus Continuous Feeding Regimens Post Gastrostomy Tube Placement

Not Applicable

Terminated

• Conditions: Enteral Nutrition; Enteral Feeding; Gastrostomy Tube
• Interventions: Procedure: Bolus feeding schedule following gastrostomy tube placement; Procedure: Continuous chimney feeds following gastrostomy tube placement

• Registration Number: NCT02006953
• Lead Sponsor: University of Michigan

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

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-10
• Primary Completion: 2018-07-18
• Study Completion: 2018-11-07
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-13
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

• Less than 18 years of age
• Admitted for gastrostomy tube placement, with or without Nissen Fundoplication

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Exclusion Criteria

• Immunocompromised patients
• Short Bowel Syndrome (SBS)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bolus	Bolus feeding schedule following gastrostomy tube placement	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.
Continuous	Continuous chimney feeds following gastrostomy tube placement	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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.
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.

Trial Locations

Locations (2)

Mercy Children's Hospital; 🇺🇸 Toledo, Ohio, United States

University of Michigan, CS Mott Children's Hospital; 🇺🇸 Ann Arbor, Michigan, United States