Blenderized diets for children with feeding intolerance
Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
This study tests whether different types of blended diets can help children with feeding intolerance by seeing how they affect reflux symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04900597 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of blenderized enteral tube feeds on pediatric patients experiencing feeding intolerance. It aims to compare the rates of gastroesophageal reflux among children receiving different types of diets: low viscosity conventional formula, medium viscosity commercial blenderized diet, and high viscosity commercial blenderized diet. Participants will be randomly assigned to receive each diet in a crossover design, allowing for direct comparison of reflux burden as measured by specialized monitoring techniques. The study also records gastric emptying scans when clinically indicated.
Who should consider this trial
Good fit: Ideal candidates are children aged 1-21 years with a gastrostomy tube who can tolerate bolus gastric feeds and are currently using conventional enteral formula.
Not a fit: Patients with a history of allergy or intolerance to any components of the test diets or those who have undergone Nissen fundoplication may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary options for children with feeding intolerance, potentially reducing reflux symptoms and hospital visits.
How similar studies have performed: Previous studies have shown promising results with blenderized diets in reducing hospital admissions and improving gastrointestinal symptoms, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Bridget M Hron, MD — Boston Children's Hospital
- Study coordinator: Bridget M Hron, MD
- Email: bridget.hron@childrens.harvard.edu
- Phone: 6173556058
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.