Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

Boston Children's Hospital200 enrolled

Overview

This study will examine the effects of varying liquid viscosity on swallow physiology in infants with oropharyngeal dysphagia and brief resolved unexplained event (BRUE) and other children with dysphagia that would be at risk for symptoms of swallow dysfunction.

Infants with oropharyngeal dysphagia and in particular brief resolved unexplained events (BRUE) are a significant driver of pediatric health care expenditure since the mechanism for their swallow dysfunction is incompletely understood and therefore frequently goes unrecognized and untreated. We hypothesize that infants with oropharyngeal dysphagia and BRUE have measurable differences in swallowing physiology to explain their symptoms of cyanotic choking spells, that these differences can be quantified using pharyngeal high resolution impedance-manometry compared to videofluoroscopic swallow study results, and that this swallowing dysfunction can be safely corrected with a change of formula viscosity. Through this research project, we will systematically investigate the effects of thickened feedings on swallow function in infants with dysphagia and BRUE and perform detailed physiology studies on pharyngeal and esophageal motility as critical mediators of improved outcomes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

200

Conditions

Dysphagia Aspiration Brief Resolved Unexplained Event (BRUE)Apparent Life Threatening Event (ALTE)

Interventions

Thin liquid swallowsDIETARY_SUPPLEMENT

Thin liquid swallows of formula or breastmilk or other liquid

Slightly thickened liquid swallowsDIETARY_SUPPLEMENT

Slightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix

Mildly thickened liquid swallowsDIETARY_SUPPLEMENT

Mildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix

Eligibility

Sex: ALLMax age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 0 to 21 years * Admitted to Boston Children's Hospital after experiencing first lifetime BRUE, or with dysphagia symptoms such that they would be at risk for BRUE or other symptoms of swallowing difficulty * Have had videofluoroscopic swallow study performed or might have future videofluoroscopic swallow study performed. Exclusion Criteria: * Any pre-existing medical diagnoses that exclude brief resolved unexplained event diagnosis including seizure disorders and cyanotic congenital heart disease * Any nasal/pharyngeal/esophageal anomalies that might affect safe placement of the pharyngeal motility catheter * Children fed exclusively by enteral tube * Allergy to rice cereal or Gelmix thickener, which will be used to adjust liquid viscosity

Locations (1)

Boston Children's Hospital

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Swallow risk indices for thin vs mildly thick vs slightly thick liquids

We will calculate swallow risk index (SRI) from impedance-manometry results to compare mean SRI with thin liquids and thickened liquids for subjects with aspiration compared to mean SRI for thin liquids and thickened liquids in subjects without aspiration.

Time frame: 30 minutes

Secondary Outcomes

Impedance-Manometry Swallow Physiology Metrics

We will measure swallow physiology metrics from impedance-manometry results, including post-swallow impedance ratio, to compare these parameters with thin liquids between subjects with and without aspiration and with varied liquid consistencies within subjects.

Time frame: 30 minutes

Central Contacts

Daniel R Duncan, MD, MPH

CONTACT

617-355-0897 daniel.duncan@childrens.harvard.edu

Data from ClinicalTrials.gov

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