NCT04900597 Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
| NCT ID | NCT04900597 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Children's Hospital |
| Condition | Enteral Feeding Intolerance |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2021-08-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2021-08-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Contact & Investigator
Bridget M Hron, MD
PRINCIPAL INVESTIGATOR
Boston Children's Hospital
Frequently Asked Questions
Who can join the NCT04900597 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, studying Enteral Feeding Intolerance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04900597 currently recruiting?
Yes, NCT04900597 is actively recruiting participants. Contact the research team at bridget.hron@childrens.harvard.edu for enrollment information.
Where is the NCT04900597 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04900597 clinical trial?
NCT04900597 is sponsored by Boston Children's Hospital. The principal investigator is Bridget M Hron, MD at Boston Children's Hospital. The trial plans to enroll 45 participants.