Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
- Conditions
- Enteral Feeding Intolerance
- Interventions
- Other: Elecare JrOther: NourishOther: Real Foods Blends
- Registration Number
- NCT04900597
- Lead Sponsor
- Boston Children's Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Real Foods Blends - Elecare - Nourish Real Foods Blends Real Foods Blends for first bolus, Elecare for second bolus, Nourish for third bolus Elecare - Nourish - Real Foods Blends Real Foods Blends Elecare for first bolus, Nourish for second bolus, Real Foods Blends for third bolus Nourish - Real Foods Blends - Elecare Elecare Jr Nourish for first bolus, Real Foods Blends for second bolus, Elecare for first bolus Real Foods Blends - Elecare - Nourish Elecare Jr Real Foods Blends for first bolus, Elecare for second bolus, Nourish for third bolus Elecare - Nourish - Real Foods Blends Elecare Jr Elecare for first bolus, Nourish for second bolus, Real Foods Blends for third bolus Nourish - Real Foods Blends - Elecare Nourish Nourish for first bolus, Real Foods Blends for second bolus, Elecare for first bolus Elecare - Nourish - Real Foods Blends Nourish Elecare for first bolus, Nourish for second bolus, Real Foods Blends for third bolus Nourish - Real Foods Blends - Elecare Real Foods Blends Nourish for first bolus, Real Foods Blends for second bolus, Elecare for first bolus Real Foods Blends - Elecare - Nourish Nourish Real Foods Blends for first bolus, Elecare for second bolus, Nourish for third bolus
- Primary Outcome Measures
Name Time Method Reflux episodes 4 hours (following feed) Number of total reflux episodes (acid and non-acid) by impedance
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States