Recruiting

Thickened Feeds

Sponsor:

Boston Children's Hospital

Code:

NCT04504227

Conditions

Dysphagia

Aspiration

Brief Resolved Unexplained Event (BRUE)

Apparent Life Threatening Event (ALTE)

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Thin liquid swallows

Slightly thickened liquid swallows

Mildly thickened liquid swallows

Moderately thickened liquid swallows

Study Details

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 dysphagia that would be at risk for symptoms of swallow dysfunction.

Conditions

Dysphagia

Aspiration

Brief Resolved Unexplained Event (BRUE)

Apparent Life Threatening Event (ALTE)

Study ID

NCT04504227

Start date

Apr 1, 2021

Status verified date

Mar, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

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

Interventions

Thin liquid swallows

Thin liquid swallows of formula or breastmilk or other liquid

Slightly thickened liquid swallows

Slightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix

Mildly thickened liquid swallows

Mildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix

Moderately thickened 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 and Locations

Central contacts

Daniel R Duncan, MD, MPH

617-355-0897daniel.duncan@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Daniel R Duncan, MD, MPH

6173550897daniel.duncan@childrens.harvard.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-03-18.