Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

Boston Children's Hospital

Status: Enrolling

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

Treatments: Dietary Supplement: Mildly thickened liquid swallows; Dietary Supplement: Slightly thickened liquid swallows; Dietary Supplement: Thin liquid swallows; Dietary Supplement: Moderately thickened liquid swallows

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04504227

IRB-P00036103

K23DK127251 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

200 participants in 4 patient groups, including a placebo group

Thin liquid swallows

Placebo Comparator group

Description:

Thin liquid swallows of formula or breastmilk or other liquid

Treatment:

Dietary Supplement: Thin liquid swallows

Slightly thick liquid swallows

Experimental group

Description:

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

Treatment:

Dietary Supplement: Slightly thickened liquid swallows

Mildly thick liquid swallows

Experimental group

Description:

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

Treatment:

Dietary Supplement: Mildly thickened liquid swallows

Moderately thick liquid swallows

Experimental group

Description:

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

Treatment:

Dietary Supplement: Moderately thickened liquid swallows