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

Enteral Feeding Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04900597
• Other study ID #: IRB-P00037093
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Boston Children's Hospital
• Contact: Bridget M Hron, MD
• Phone: 6173556058
• Email: bridget.hron[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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)

Related Conditions & MeSH terms

• Enteral Feeding Intolerance

Intervention

Other:
• Elecare Jr
Elecare Jr is a standard pediatric elemental formula
• Nourish
Nourish is a commercially prepared blenderized tube feed that is formulated for pediatric use
• Real Foods Blends
Real Foods Blends is a commercially prepared blenderized tube feed that is formulated for pediatric use

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	1 hour
Primary	Reflux episodes	Number of total reflux episodes (acid and non-acid) by impedance	4 hours (following feed)
Secondary	Full column reflux episodes	Total number of full-column reflux episodes by impedance	4 hours (following feed)
Secondary	Percent of time esophageal pH < 4	Percent of time esophageal pH < 4 by impedance	4 hours after feed
Secondary	Average height of refluxate	Average height of refluxate by impedance	4 hours after feed
Secondary	Number of symptoms	Frequency of pulmonary and gastrointestinal symptoms from questionnaires during impedance	4 hours after feed