Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology

Study Overview
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Brief Summary
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Blenderized diets consist of a wide range of table foods such as fruits, vegetables, meat and legumes, pureed in a blender and administered via gastrostomy tube. In a recent study, the investigators reported that children receiving blenderized feeds via gastrostomy had fewer total admissions and respiratory admissions, total emergency room visits, and improved gastrointestinal symptom scores compared to those fed formula. The goal of this project is to understand how these diets affect gastroesophageal reflux burden.

Detailed Description
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The investigators hypothesize that rates of gastroesophageal reflux will be lower in blenderized diets compared to formula. The investigators will determine if reflux burden as measured by multichannel intraluminal impedance/esophageal pH monitoring performed for clinical purposes differs between low viscosity conventional formula, medium viscosity commercial blenderized diet, and high viscosity commercial blenderized diet in 45 children receiving conventional formula via gastrostomy. All participants will receive each of the three test diets in random order in a 3-way crossover design. Results of gastric emptying scans will be recorded if done for clinical purposes.

Official Title
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Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology

Conditions
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Enteral Feeding Intolerance

Intervention / Treatment
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* Other: Elecare Jr
* Other: Nourish
* Other: Real Foods Blends


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 1-21 years G-tube Able to tolerate bolus gastric feeds over 30 minutes Use of conventional enteral formula Undergoing impedance study for clinical purposes Exclusion Criteria: History of allergy or intolerance to any component of the test diets History of Nissen fundoplication Current use of non-invasive pressure support (continuous or bi-level positive airway pressure)

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elecare - Nourish - Real Foods Blends<br>Elecare for first bolus, Nourish for second bolus, Real Foods Blends for third bolus | Other: Elecare Jr<br>* Elecare Jr is a standard pediatric elemental formula<br>Other: Nourish<br>* Nourish is a commercially prepared blenderized tube feed that is formulated for pediatric use<br>Other: Real Foods Blends<br>* Real Foods Blends is a commercially prepared blenderized tube feed that is formulated for pediatric use<br>|
| Experimental: Nourish - Real Foods Blends - Elecare<br>Nourish for first bolus, Real Foods Blends for second bolus, Elecare for first bolus | Other: Elecare Jr<br>* Elecare Jr is a standard pediatric elemental formula<br>Other: Nourish<br>* Nourish is a commercially prepared blenderized tube feed that is formulated for pediatric use<br>Other: Real Foods Blends<br>* Real Foods Blends is a commercially prepared blenderized tube feed that is formulated for pediatric use<br>|
| Experimental: Real Foods Blends - Elecare - Nourish<br>Real Foods Blends for first bolus, Elecare for second bolus, Nourish for third bolus | Other: Elecare Jr<br>* Elecare Jr is a standard pediatric elemental formula<br>Other: Nourish<br>* Nourish is a commercially prepared blenderized tube feed that is formulated for pediatric use<br>Other: Real Foods Blends<br>* Real Foods Blends is a commercially prepared blenderized tube feed that is formulated for pediatric use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflux episodes | Number of total reflux episodes (acid and non-acid) by impedance | 4 hours (following feed) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Full column reflux episodes | Total number of full-column reflux episodes by impedance | 4 hours (following feed) | 
| Percent of time esophageal pH < 4 | Percent of time esophageal pH < 4 by impedance | 4 hours after feed | 
| Average height of refluxate | Average height of refluxate by impedance | 4 hours after feed | 
| Number of symptoms | Frequency of pulmonary and gastrointestinal symptoms from questionnaires during impedance | 4 hours after feed |