About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 1-21 years
G-tube
Able to tolerate bolus gastric feeds over 30 minutes
Use of conventional enteral formula
Disqualifiers
History of allergy or intolerance to any component of the test diets
History of Nissen fundoplication (participants with suspected or documented unwrapped fundoplication will be eligible for participation)
Current use of non-invasive pressure support (continuous or bi-level positive airway pressure)
Trial design
Crossover
Treatments tested in this trial
Elecare Jr
Other interventionElecare Jr is a standard pediatric elemental formula
Nourish
Other interventionNourish is a commercially prepared blenderized tube feed that is formulated for pediatric use
Real Foods Blends
Other interventionReal Foods Blends is a commercially prepared blenderized tube feed that is formulated for pediatric use
Treatment groups
Trial outcomes
Primary outcomes
Reflux episodes
Number of total reflux episodes (acid and non-acid) by impedance
Secondary outcomes
Full column reflux episodes
Total number of full-column reflux episodes by impedance
Percent of time esophageal pH < 4
Percent of time esophageal pH \< 4 by impedance
Average height of refluxate
Average height of refluxate by impedance
Number of symptoms
Frequency of pulmonary and gastrointestinal symptoms from questionnaires during impedance
Other outcomes
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
Sponsors and contacts
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