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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elecare - Nourish - Real Foods Blends | Experimental | Elecare for first bolus, Nourish for second bolus, Real Foods Blends for third bolus |
|
| Nourish - Real Foods Blends - Elecare | Experimental | Nourish for first bolus, Real Foods Blends for second bolus, Elecare for first bolus |
|
| Real Foods Blends - Elecare - Nourish | Experimental | Real Foods Blends for first bolus, Elecare for second bolus, Nourish for third bolus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elecare Jr | Other | Elecare Jr is a standard pediatric elemental formula |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reflux episodes | Number of total reflux episodes (acid and non-acid) by impedance | 4 hours (following feed) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric emptying (percent of ingested contents remaining in stomach at 1 hour) | Gastric emptying scans by scintigraphy will be analyzed if performed for clinical reasons | 1 hour |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bridget M Hron, MD | Contact | 6173556058 | bridget.hron@childrens.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bridget M Hron, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| Nourish | Other | Nourish is a commercially prepared blenderized tube feed that is formulated for pediatric use |
|
| Real Foods Blends | Other | Real Foods Blends is a commercially prepared blenderized tube feed that is formulated for pediatric use |
|
| 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 |