Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT04504227
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Thin liquid swallows — DIETARY_SUPPLEMENT
    Thin liquid swallows of formula or breastmilk or other liquid
  • Slightly thickened liquid swallows — DIETARY_SUPPLEMENT
    Slightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
  • Mildly thickened liquid swallows — DIETARY_SUPPLEMENT
    Mildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
  • Moderately thickened liquid swallows — DIETARY_SUPPLEMENT
    Moderately thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix

Study Details

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.

Key Dates

Start date
Apr 1, 2021
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC

Arms

  • Placebo Comparator: Thin liquid swallows
    Thin liquid swallows of formula or breastmilk or other liquid
  • Experimental: Slightly thick liquid swallows
    Slightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
  • Experimental: Mildly thick liquid swallows
    Mildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
  • Experimental: Moderately thick liquid swallows
    Moderately thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix

Primary Outcome Measure

Swallow risk indices for thin vs mildly thick vs slightly thick liquids [ Time Frame: 30 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Daniel R Duncan, MD, MPH
[email protected]
6173550897

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By research site
Boston Children's Hospital· Boston, MA

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