NCT04504227

Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Thin liquid swallows	Thin liquid swallows of formula or breastmilk or other liquid
DIETARY_SUPPLEMENT	Slightly thickened liquid swallows	Slightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
DIETARY_SUPPLEMENT	Mildly thickened liquid swallows	Mildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
DIETARY_SUPPLEMENT	Moderately thickened liquid swallows	Moderately thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix

Timeline

• Start date: 2021-04-01
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2020-08-07
• Last updated: 2026-03-18

Locations

1 site across 1 country: United States