Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1+
SponsorBoston Children's Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age 1-21 years

G-tube

Able to tolerate bolus gastric feeds over 30 minutes

Use of conventional enteral formula

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Elecare Jr

    Other intervention

    Elecare Jr is a standard pediatric elemental formula

  • Nourish

    Other intervention

    Nourish is a commercially prepared blenderized tube feed that is formulated for pediatric use

  • Real Foods Blends

    Other intervention

    Real Foods Blends is a commercially prepared blenderized tube feed that is formulated for pediatric use

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Elecare - Nourish - Real Foods BlendsExperimental treatment 3 interventions
Group B: Nourish - Real Foods Blends - ElecareExperimental treatment 3 interventions
Group C: Real Foods Blends - Elecare - NourishExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Reflux episodes

Number of total reflux episodes (acid and non-acid) by impedance

Time frame
4 hours (following feed)

Secondary outcomes

1

Full column reflux episodes

Total number of full-column reflux episodes by impedance

Time frame
4 hours (following feed)
2

Percent of time esophageal pH < 4

Percent of time esophageal pH \< 4 by impedance

Time frame
4 hours after feed
3

Average height of refluxate

Average height of refluxate by impedance

Time frame
4 hours after feed
4

Number of symptoms

Frequency of pulmonary and gastrointestinal symptoms from questionnaires during impedance

Time frame
4 hours after feed

Other outcomes

1

Gastric emptying (percent of ingested contents remaining in stomach at 1 hour)

Gastric emptying scans by scintigraphy will be analyzed if performed for clinical reasons

Time frame
1 hour

Sponsors and contacts

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