Bolus Versus Continuous Feeding Regimens Post Gastrostomy Tube Placement

University of Michigan

Status: Terminated

Conditions: Enteral Feeding; Enteral Nutrition; Gastrostomy Tube

Treatments: Procedure: Bolus feeding schedule following gastrostomy tube placement; Procedure: Continuous chimney feeds following gastrostomy tube placement

Study type: Interventional

Funder types: Other

Identifiers

NCT02006953

HUM00046483

Details and patient eligibility

About

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.

Full description

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

Enrollment: 97 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

Bolus

Active Comparator group

Description:

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.

Treatment:

Procedure: Bolus feeding schedule following gastrostomy tube placement

Continuous

Active Comparator group

Description:

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.

Treatment:

Procedure: Continuous chimney feeds following gastrostomy tube placement