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Difficulty recruiting due to parent declining feeding strategy
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| Name | Class |
|---|---|
| Children's Mercy Hospital Kansas City | OTHER |
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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.
This study will consist of a prospective, randomized comparison of bolus versus continuous enteral feeding protocols in pediatric patients with gastrostomy tubes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bolus | Active Comparator | 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. |
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| Continuous | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bolus feeding schedule following gastrostomy tube placement | Procedure |
| ||
| Continuous chimney feeds following gastrostomy tube placement |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven W Bruch, MD, MSc | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan, CS Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States | ||
| Mercy Children's Hospital |
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| Procedure |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 8 weeks |
| Toledo |
| Ohio |
| 43608 |
| United States |