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

Boston Children's Hospital

Status: Enrolling

Conditions: Enteral Feeding Intolerance

Treatments: Other: Real Foods Blends; Other: Nourish; Other: Elecare Jr

Study type: Interventional

Funder types: Other

Identifiers

NCT04900597

IRB-P00037093

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 1 to 21 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Elecare - Nourish - Real Foods Blends

Experimental group

Description:

Elecare for first bolus, Nourish for second bolus, Real Foods Blends for third bolus

Treatment:

Other: Elecare Jr

Other: Nourish

Other: Real Foods Blends

Nourish - Real Foods Blends - Elecare

Experimental group

Description:

Nourish for first bolus, Real Foods Blends for second bolus, Elecare for first bolus

Treatment:

Other: Elecare Jr

Other: Nourish

Other: Real Foods Blends

Real Foods Blends - Elecare - Nourish

Experimental group

Description:

Real Foods Blends for first bolus, Elecare for second bolus, Nourish for third bolus

Treatment:

Other: Elecare Jr

Other: Nourish

Other: Real Foods Blends