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NCT Number: NCT04504227

Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

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.

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Key information

About this study

Infants with oropharyngeal dysphagia and in particular brief resolved unexplained events (BRUE) are a significant driver of pediatric health care expenditure since the mechanism for their swallow dysfunction is incompletely understood and therefore frequently goes unrecognized and untreated. We hypothesize that infants with oropharyngeal dysphagia and BRUE have measurable differences in swallowing physiology to explain their symptoms of cyanotic choking spells, that these differences can be quantified using pharyngeal high resolution impedance-manometry compared to videofluoroscopic swallow study results, and that this swallowing dysfunction can be safely corrected with a change of formula viscosity. Through this research project, we will systematically investigate the effects of thickened feedings on swallow function in infants with dysphagia and BRUE and perform detailed physiology studies on pharyngeal and esophageal motility as critical mediators of improved outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Swallow risk indices for thin vs mildly thick vs slightly thick liquids

    Time frame: 30 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.

Secondary outcomes

  1. Impedance-Manometry Swallow Physiology Metrics

    Time frame: 30 minutes

    We will measure swallow physiology metrics from impedance-manometry results, including post-swallow impedance ratio, to compare these parameters with thin liquids between subjects with and without aspiration and with varied liquid consistencies within subjects.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel R Duncan, MD, MPH

CONTACT

[email protected]

617-355-0897

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2020
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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