Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

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

Intervention / Treatment
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* Dietary Supplement: Thin liquid swallows
* Dietary Supplement: Slightly thickened liquid swallows
* Dietary Supplement: Mildly thickened liquid swallows
* Dietary Supplement: Moderately thickened liquid swallows


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 4-test consistency, randomized, crossover, single-blinded swallow physiology study comparing effects of different liquid viscosities on swallow coordination in infants and children
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Thin liquid swallows<br>Thin liquid swallows of formula or breastmilk or other liquid | Dietary Supplement: Thin liquid swallows<br>* Thin liquid swallows of formula or breastmilk or other liquid<br>|
| Experimental: Slightly thick liquid swallows<br>Slightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix | Dietary Supplement: Slightly thickened liquid swallows<br>* Slightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix<br>|
| Experimental: Mildly thick liquid swallows<br>Mildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix | Dietary Supplement: Mildly thickened liquid swallows<br>* Mildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix<br>|
| Experimental: Moderately thick liquid swallows<br>Moderately thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix | Dietary Supplement: Moderately thickened liquid swallows<br>* Moderately thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 minutes |