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
June 22, 2023
Principal Investigator
Daniel Duncan
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: