NCT02006953 - Bolus Versus Continuous Feeding Regimens Post Gastrostomy Tube Placement | Crick | Crick

Bolus Versus Continuous Feeding Regimens Post Gastrostomy Tube Placement

N/ATerminatedNCT02006953

University of Michigan97 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

97

Conditions

Enteral Nutrition Enteral Feeding Gastrostomy Tube

Interventions

Bolus feeding schedule following gastrostomy tube placementPROCEDURE

Continuous chimney feeds following gastrostomy tube placementPROCEDURE

Eligibility

Sex: ALLMax age: 17 Years

Medical Language ↔ Plain English

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)

Locations (2)

University of Michigan, CS Mott Children's Hospital

Ann Arbor, Michigan, United States

Mercy Children's Hospital

Toledo, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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