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

Conditions

• Enteral Feeding Intolerance

Eligibility Criteria

Sex

ALL

Age

1 Year - N/A

Healthy Volunteers

Not accepted

Interventions

• Elecare Jr — OTHER
  Elecare Jr is a standard pediatric elemental formula
• 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

Study Details

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.

Key Dates

Start date

Aug 1, 2021

Status verified

Mar 2026

Primary completion

Jul 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

45 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Elecare - Nourish - Real Foods Blends
  Elecare for first bolus, Nourish for second bolus, Real Foods Blends for third bolus
• Experimental: Nourish - Real Foods Blends - Elecare
  Nourish for first bolus, Real Foods Blends for second bolus, Elecare for first bolus
• Experimental: Real Foods Blends - Elecare - Nourish
  Real Foods Blends for first bolus, Elecare for second bolus, Nourish for third bolus

Primary Outcome Measure

Reflux episodes [ Time Frame: 4 hours (following feed) ]

Central Contacts

• Bridget M Hron, MD
  6173556058
  [email protected]

Locations (1)

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