Bolus Versus Continuous Feeding Regimens Post Gastrostomy Tube Placement

• Sponsor: University of Michigan (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02006953
• Collaborator: Children's Mercy Hospital Kansas City (Other)
• Enrollment: 97
• Locations: 2
• Arms: 2
• Duration (Months): 87.2
• Patients Per Site: 48.5
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Enteral Nutrition; Enteral Feeding; Gastrostomy Tube	Procedure: Bolus feeding schedule following gastrostomy tube placement; Procedure: Continuous chimney feeds following gastrostomy tube placement	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 97 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Bolus Versus Continuous Feeding Regimens Post Gastrostomy Tube Placement
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Jul 18, 2018
• Actual Study Completion Date: Nov 7, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: Bolus feeding schedule following gastrostomy tube placement
Active Comparator: 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.	Procedure: Continuous chimney feeds following gastrostomy tube placement

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan, CS Mott Children's Hospital	Ann Arbor	Michigan	United States	48109
2	Mercy Children's Hospital	Toledo	Ohio	United States	43608

Sponsors and Collaborators

• University of Michigan
• Children's Mercy Hospital Kansas City

Investigators

• Principal Investigator: Steven W Bruch, MD, MSc, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Steven W. Bruch, M.D., MSc., Clinical Associate Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT02006953
• Other Study ID Numbers: HUM00046483
• First Posted: Dec 10, 2013
• Last Update Posted: Jan 15, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Steven W. Bruch, M.D., MSc., Clinical Associate Professor, University of Michigan: gastrostomy; enteral

Study Results

No Results Posted as of Jan 15, 2019