Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Elecare - Nourish - Real Foods Blends Elecare for first bolus, Nourish for second bolus, Real Foods Blends for third bolus |
Other: Elecare Jr
Elecare Jr is a standard pediatric elemental formula
Other: Nourish
Nourish is a commercially prepared blenderized tube feed that is formulated for pediatric use
Other: Real Foods Blends
Real Foods Blends is a commercially prepared blenderized tube feed that is formulated for pediatric use
|
| Experimental: Nourish - Real Foods Blends - Elecare Nourish for first bolus, Real Foods Blends for second bolus, Elecare for first bolus |
Other: Elecare Jr
Elecare Jr is a standard pediatric elemental formula
Other: Nourish
Nourish is a commercially prepared blenderized tube feed that is formulated for pediatric use
Other: Real Foods Blends
Real Foods Blends is a commercially prepared blenderized tube feed that is formulated for pediatric use
|
| Experimental: Real Foods Blends - Elecare - Nourish Real Foods Blends for first bolus, Elecare for second bolus, Nourish for third bolus |
Other: Elecare Jr
Elecare Jr is a standard pediatric elemental formula
Other: Nourish
Nourish is a commercially prepared blenderized tube feed that is formulated for pediatric use
Other: Real Foods Blends
Real Foods Blends is a commercially prepared blenderized tube feed that is formulated for pediatric use
|
Outcome Measures
Primary Outcome Measures
- Reflux episodes [4 hours (following feed)]
Number of total reflux episodes (acid and non-acid) by impedance
Secondary Outcome Measures
- Full column reflux episodes [4 hours (following feed)]
Total number of full-column reflux episodes by impedance
- Percent of time esophageal pH < 4 [4 hours after feed]
Percent of time esophageal pH < 4 by impedance
- Average height of refluxate [4 hours after feed]
Average height of refluxate by impedance
- Number of symptoms [4 hours after feed]
Frequency of pulmonary and gastrointestinal symptoms from questionnaires during impedance
Other Outcome Measures
- Gastric emptying (percent of ingested contents remaining in stomach at 1 hour) [1 hour]
Gastric emptying scans by scintigraphy will be analyzed if performed for clinical reasons
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boston Children's Hospital | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Boston Children's Hospital
Investigators
- Principal Investigator: Bridget M Hron, MD, Boston Children's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-P00037093