Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

  • STATUS
    Recruiting
  • End date
    Aug 31, 2025
  • participants needed
    200
  • sponsor
    Boston Children's Hospital
Updated on 25 July 2022

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.

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.

Details
Condition Dysphagia, Aspiration, Brief Resolved Unexplained Event (BRUE), Apparent Life Threatening Event (ALTE)
Treatment Thin liquid swallows, Slightly thickened liquid swallows, Mildly thickened liquid swallows, Moderately thickened liquid swallows
Clinical Study IdentifierNCT04504227
SponsorBoston Children's Hospital
Last Modified on25 July 2022

Eligibility

Yes No Not Sure

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
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