Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

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)

Interventions

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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Boston Children's Hospital

  lead OTHER

Principal Investigators

• Daniel R Duncan, MD, MPH · Boston Children's Hospital

• Rachel Rosen, MD, MPH · Boston Children's Hospital

• Sudarshan Jadcherla, MD · Nationwide Children's Hospital

• Taher Omari, PhD · Flinders University

• Samuel Nurko, MD, MPH · Boston Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

CROSSOVER

Eligibility

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-01

Primary Completion

2026-08-31

Completion

2026-08-31

Countries

• United States

Study Locations