Bolus Versus Continuous Feeding Regimens Post Gastrostomy Tube Placement

Enteral Nutrition Clinical Trial

Official title:

Bolus Versus Continuous Feeding Regimens Post Gastrostomy Tube Placement

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02006953
• Other study ID #: HUM00046483
• Status: Terminated
• Phase: N/A
• Start date: August 2011
• Est. completion date: November 7, 2018

Study information

• Verified date: January 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 97
• Est. completion date: November 7, 2018
• Est. primary completion date: July 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Enteral Feeding
• Enteral Nutrition
• Gastrostomy Tube

Intervention

Procedure:
• Bolus feeding schedule following gastrostomy tube placement

• Continuous chimney feeds following gastrostomy tube placement

Locations

Country	Name	City	State
United States	University of Michigan, CS Mott Children's Hospital	Ann Arbor	Michigan
United States	Mercy Children's Hospital	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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