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Search / Trial NCT04504227

Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

Launched by BOSTON CHILDREN'S HOSPITAL · Aug 6, 2020

Trial Information

Current as of July 12, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how different thickness levels of liquids affect swallowing in children who have difficulty swallowing, known as dysphagia. The study specifically focuses on infants and children who have experienced a first-time unexplained event where they might have had trouble breathing or swallowing. By adjusting the thickness of their liquids, the researchers hope to learn how it impacts their ability to swallow safely.

To participate in this study, children aged 0 to 21 years who have been admitted to Boston Children's Hospital for swallowing difficulties or related issues may be eligible. Participants will likely have a special swallowing test done, called a videofluoroscopic swallow study, to assess how well they can swallow different types of liquids. It's important to note that children with certain medical conditions or allergies to the thickening agents used in the study may not be able to join. Overall, this trial aims to help improve swallowing safety in children with dysphagia.

Gender

ALL

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

About Boston Children's Hospital

Boston Children's Hospital is a leading pediatric healthcare institution renowned for its commitment to advancing child health through innovative research and exceptional clinical care. As a prominent clinical trial sponsor, the hospital leverages its extensive expertise in pediatric medicine to conduct rigorous and ethically sound research studies aimed at improving treatment options and outcomes for children. With a collaborative approach that integrates cutting-edge technology and multidisciplinary teams, Boston Children's Hospital is dedicated to translating scientific discoveries into practical applications that enhance the well-being of young patients and their families.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Daniel R Duncan, MD, MPH

Principal Investigator

Boston Children's Hospital

Rachel Rosen, MD, MPH

Study Director

Boston Children's Hospital

Sudarshan Jadcherla, MD

Study Director

Nationwide Children's Hospital

Taher Omari, PhD

Study Director

Flinders University

Samuel Nurko, MD, MPH

Study Director

Boston Children's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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