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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours after feed
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
766 Previous Clinical Trials
5,580,744 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for enrollment in this trial restricted to those under 75 years old?

"This clinical study is seeking participants of between one and twenty-one years old."

Answered by AI

Are there still openings for participants in this medical experiment?

"In accordance with the data on clinicaltrials.gov, this ongoing medical trial is in search of suitable participants. The study was initially announced on August 1st 2021 and its most recent update was made available November 5th 2021."

Answered by AI

What is the sample size of this research endeavor?

"Affirmative. An inspection of clinicaltrials.gov reveals that this medical study, which was launched on August 1st 2021, is actively recruiter participants. There is a requirement for 45 volunteers to be enrolled between one location."

Answered by AI

Is my participation permissible in this clinical trial?

"45 persons that suffer from lactose intolerance, between the ages of one and twenty-one years old, are being admitted for this trial. To be eligible for enrolment, patients must meet two conditions: they have to age 1-21 years and demonstrate their capability to endure gastric bolus feeds over a period of 30 minutes."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
How old are they?
18 - 65
What site did they apply to?
Boston Children's Hospital
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
Bridget Hron 2021. "Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04900597.
~7 spots leftby Dec 2024
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