Enteral Feeding Intolerance
Conditions
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.
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.
Interventions
OTHERElecare Jr
Elecare Jr is a standard pediatric elemental formula
OTHERNourish
Nourish is a commercially prepared blenderized tube feed that is formulated for pediatric use
OTHERReal Foods Blends
Real Foods Blends is a commercially prepared blenderized tube feed that is formulated for pediatric use
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
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 (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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reflux episodes | 4 hours (following feed) | Number of total reflux episodes (acid and non-acid) by impedance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTBridget M Hron, MD
PRINCIPAL_INVESTIGATORBridget M Hron, MD
Boston Children's Hospital
Outcome results
None listed