Study Stopped
Difficulty recruiting due to parent declining feeding strategy
Bolus Versus Continuous Feeding Regimens Post Gastrostomy Tube Placement
1 other identifier
interventional
97
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2011
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 5, 2013
CompletedFirst Posted
Study publicly available on registry
December 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2018
CompletedJanuary 15, 2019
January 1, 2019
7 years
December 5, 2013
January 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Emesis
8 weeks
Retching
8 weeks
Venting beyond recommendations
8 weeks
Feeding changes
8 weeks
Unscheduled clinic/ER visits/calls
8 weeks
- +3 more secondary outcomes
Study Arms (2)
Bolus
ACTIVE COMPARATORBolus: 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.
Continuous
ACTIVE COMPARATORContinuous: 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.
Interventions
Eligibility Criteria
You may qualify if:
- Less than 18 years of age
- Admitted for gastrostomy tube placement, with or without Nissen Fundoplication
You may not qualify if:
- Immunocompromised patients
- Short Bowel Syndrome (SBS)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- Children's Mercy Hospital Kansas Citycollaborator
Study Sites (2)
University of Michigan, CS Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Mercy Children's Hospital
Toledo, Ohio, 43608, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Steven W Bruch, MD, MSc
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., MSc., Clinical Associate Professor
Study Record Dates
First Submitted
December 5, 2013
First Posted
December 10, 2013
Study Start
August 1, 2011
Primary Completion
July 18, 2018
Study Completion
November 7, 2018
Last Updated
January 15, 2019
Record last verified: 2019-01