Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

Not Applicable

Recruiting

• Conditions: Dysphagia; Aspiration; Apparent Life Threatening Event (ALTE); Brief Resolved Unexplained Event (BRUE)
• Interventions: Dietary Supplement: Moderately thickened liquid swallows; Dietary Supplement: Thin liquid swallows; Dietary Supplement: Slightly thickened liquid swallows; Dietary Supplement: Mildly thickened liquid swallows

• Registration Number: NCT04504227
• Lead Sponsor: Boston Children's Hospital

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-07
• Study Start: 2021-04-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Moderately thick liquid swallows	Moderately thickened liquid swallows	Moderately thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
Thin liquid swallows	Thin liquid swallows	Thin liquid swallows of formula or breastmilk or other liquid
Slightly thick liquid swallows	Slightly thickened liquid swallows	Slightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
Mildly thick liquid swallows	Mildly thickened liquid swallows	Mildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix

Primary Outcome Measures

Name	Time	Method
Swallow risk indices for thin vs mildly thick vs slightly thick liquids	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 Outcome Measures

Name	Time	Method
Impedance-Manometry Swallow Physiology Metrics	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.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States