An interventional study of Bolus feeding schedule following gastrostomy tube placement and Continuous chimney feeds following gastrostomy tube placement in Enteral Nutrition, Enteral Feeding and Gastrostomy Tube, sponsored by University of Michigan. Terminated at 2 sites in United States. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2019-01-15.
Sponsored by University of Michigan · Not applicable, Interventional, and Supportive care
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
University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
Weight
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
Time to goal feeds
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
This study is terminated, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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