RecruitingNot ApplicableNCT04504227

Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia


Sponsor

Boston Children's Hospital

Enrollment

200 participants

Start Date

Apr 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study at Boston Children's Hospital investigates whether thickening liquids can help children with swallowing difficulties (dysphagia). Thickened liquids are commonly recommended for children who aspirate (inhale) thin fluids, but little is known about how exactly they change swallowing mechanics. Researchers use a special type of X-ray called a videofluoroscopic swallow study to measure how the throat muscles move with different liquid thicknesses. The study enrolls children up to 21 years old who have swallowing difficulties or who experienced a brief resolved unexplained event (BRUE — a sudden alarming episode in an infant). It is observational and may include children who already had or may have a swallowing study in the future. You may be eligible if: - Your child is 21 years old or younger - Your child was admitted to Boston Children's Hospital after a first-lifetime BRUE, or has swallowing difficulties - Your child has had or may have a videofluoroscopic swallow study You may NOT be eligible if: - Your child has a pre-existing condition that rules out BRUE (e.g., seizure disorder, cyanotic congenital heart disease) - Your child has nasal, throat, or esophageal abnormalities that make catheter placement unsafe - Your child is fed exclusively by feeding tube - Your child is allergic to rice cereal or Gelmix thickener Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTThin liquid swallows

Thin liquid swallows of formula or breastmilk or other liquid

DIETARY_SUPPLEMENTSlightly thickened liquid swallows

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

DIETARY_SUPPLEMENTMildly thickened liquid swallows

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

DIETARY_SUPPLEMENTModerately thickened liquid swallows

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


Locations(1)

Boston Children's Hospital

Boston, Massachusetts, United States

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NCT04504227


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