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Behavioural Intervention

Blenderized Diets for Enteral Feeding Intolerance

N/A
Recruiting
Led By Bridget M Hron, MD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not have
Current use of non-invasive pressure support (continuous or bi-level positive airway pressure)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours after feed
Awards & highlights
No Placebo-Only Group

Summary

This trial will investigate whether or not a blenderized diet improves gastrointestinal symptoms and reduces hospital admissions in children.

Who is the study for?
This trial is for children and young adults aged 1-21 who are currently using a gastrostomy tube (G-tube) for feeding. They should be able to handle bolus gastric feeds over 30 minutes and use conventional enteral formula. Those with a history of stomach surgery, using airway pressure support, or allergies to the test diets' components cannot participate.
What is being tested?
The study examines how blenderized diets affect kids with feeding tubes compared to standard formulas. Blenderized diets include pureed normal foods like fruits and meats. The focus is on their impact on gastroesophageal reflux, which can cause discomfort and complications in these patients.
What are the potential side effects?
While not explicitly stated, potential side effects may include changes in digestion or comfort levels due to different food consistencies and nutritional compositions when switching from standard formulas to blenderized foods.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I use a CPAP or BiPAP machine for breathing support.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 hours after feed
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 hours after feed for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reflux episodes
Secondary study objectives
Average height of refluxate
Full column reflux episodes
Number of symptoms
+1 more
Other study objectives
Gastric emptying (percent of ingested contents remaining in stomach at 1 hour)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Real Foods Blends - Elecare - NourishExperimental Treatment3 Interventions
Real Foods Blends for first bolus, Elecare for second bolus, Nourish for third bolus
Group II: Nourish - Real Foods Blends - ElecareExperimental Treatment3 Interventions
Nourish for first bolus, Real Foods Blends for second bolus, Elecare for first bolus
Group III: Elecare - Nourish - Real Foods BlendsExperimental Treatment3 Interventions
Elecare for first bolus, Nourish for second bolus, Real Foods Blends for third bolus

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
789 Previous Clinical Trials
5,582,861 Total Patients Enrolled
Bridget M Hron, MDPrincipal InvestigatorBoston Children's Hospital

Media Library

Blenderized Enteral Tube Feeds (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04900597 — N/A
Enteral Feeding Intolerance Research Study Groups: Real Foods Blends - Elecare - Nourish, Elecare - Nourish - Real Foods Blends, Nourish - Real Foods Blends - Elecare
Enteral Feeding Intolerance Clinical Trial 2023: Blenderized Enteral Tube Feeds Highlights & Side Effects. Trial Name: NCT04900597 — N/A
Blenderized Enteral Tube Feeds (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04900597 — N/A
~10 spots leftby Jan 2026
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