Bolus Versus Continuous Feeding Regimens Post Gastrostomy Tube Placement

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.

Study Overview

• Status: Terminated
• Conditions: Enteral Nutrition; Enteral Feeding; Gastrostomy Tube
• Intervention / Treatment: Procedure: Bolus feeding schedule following gastrostomy tube placement; Procedure: Continuous chimney feeds following gastrostomy tube placement

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 Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan, CS Mott Children's Hospital
  • Ohio
    • Toledo, Ohio, United States, 43608
      • Mercy Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bolus; 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
Active Comparator: Continuous; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Children's Mercy Hospital Kansas City
• Investigators: Principal Investigator: Steven W Bruch, MD, MSc, University of Michigan

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): July 18, 2018
• Study Completion (Actual): November 7, 2018

Study Registration Dates

• First Submitted: December 5, 2013
• First Submitted That Met QC Criteria: December 5, 2013
• First Posted (Estimate): December 10, 2013

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 13, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: gastrostomy; enteral
• Other Study ID Numbers: HUM00046483

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No