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Thickened Feeds for Children with Swallowing Difficulties

This study is looking at how different thicknesses of liquids affect swallowing in children with dysphagia (difficulty swallowing) or a history of Brief Resolved Unexplained Events (BRUE) or Apparent Life Threatening Events (ALTE). Researchers will compare thin liquids to slightly, mildly, and moderately thickened liquids (like formula or breastmilk thickened with rice cereal or Gelmix). The goal is to understand if changing liquid thickness can help correct swallowing problems. You might be able to join if you are between 0 and 21 years old, are admitted to Boston Children's Hospital for BRUE or dysphagia, and have had or might have a videofluoroscopic swallow study. The study aims to enroll 200 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive different treatments. It plans to enroll 200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Swallow risk will be measured at 30 minutes after receiving different liquid thicknesses.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04504227

Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

Recruiting
NAUp to 21InterventionalDiagnostic
Boston Children's Hospital
~200 participants
Updated 2026-03-18 on ClinicalTrials.gov
What's tested:Thin liquid swallowsSlightly thickened liquid swallowsMildly thickened liquid swallowsModerately thickened liquid swallows

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Swallow risk indices for thin vs mildly thick vs slightly thick liquids
Measured over 30 minutes

Conditions

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

Explore related trials

Apparent Life Threatening EventAspirationBrief resolved unexplained eventDysphagia

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • 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

Who to contact

Daniel R Duncan, MD, MPH
[email protected]
617-355-0897
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Swallow risk indices for thin vs mildly thick vs slightly thick liquids30 minutes

    We will calculate swallow risk index (SRI) from impedance-manometry results to compare mean SRI with thin liquids and thickened liquids for subjects with aspiration compared to mean SRI for thin liquids and thickened liquids in subjects without aspiration.