Bolus Versus Continuous Feeding Regimens Post Gastrostomy Tube Placement

NCT ID: NCT02006953

Last Updated: 2019-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2018-11-07

Brief Summary

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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

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

Conditions

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Enteral Nutrition Enteral Feeding Gastrostomy Tube

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Bolus feeding schedule following gastrostomy tube placement

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Continuous chimney feeds following gastrostomy tube placement

Intervention Type PROCEDURE

Interventions

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Bolus feeding schedule following gastrostomy tube placement

Intervention Type PROCEDURE

Continuous chimney feeds following gastrostomy tube placement

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Mercy Hospital Kansas City

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Steven W. Bruch

M.D., MSc., Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven W Bruch, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan, CS Mott Children's Hospital

Ann Arbor, Michigan, United States

Site Status

Mercy Children's Hospital

Toledo, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00046483

Identifier Type: -

Identifier Source: org_study_id

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