Status:
RECRUITING
Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Dysphagia
Aspiration
Eligibility:
All Genders
Up to 21 years
Phase:
NA
Brief 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 dyspha...
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 dysf...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04504227
Start Date
April 1 2021
End Date
August 31 2026
Last Update
December 10 2025
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115