Current Environment:

Summary

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.

Conditions

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

Recruitment Status

Recruiting

Detailed Description

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.

Eligibility Criteria

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

Intervention

Intervention Type

Intervention Name

Dietary Supplement

Thin liquid swallows

Dietary Supplement

Slightly thickened liquid swallows

Dietary Supplement

Mildly thickened liquid swallows

Dietary Supplement

Moderately thickened liquid swallows

Phase

Not Applicable

Gender

All

Min Age

0 Months

Max Age

21 Years

Download Date

July 19, 2022

Principal Investigator

Daniel Duncan

Primary Contact Information

Daniel R Duncan, MD, MPH

617-355-0897

daniel.duncan@childrens.harvard.edu

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: