Bolus Versus Continuous Feeding Regimens Post Gastrostomy Tube Placement

Not Applicable

Terminated

• Conditions: Enteral Nutrition; Enteral Feeding; Gastrostomy Tube

• 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

Exclusion Criteria

• Immunocompromised patients
• Short Bowel Syndrome (SBS)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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.
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.
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.
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)

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

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