Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pediatric Dysphagia Outcomes After Injection Laryngoplasty for Type I Laryngeal Cleft

NCT01507207

Dysphagia Aspiration Quality of Life

COMPLETED PHASE4

Oropharyngeal Dysphagia in Patients With Community Acquired Pneumonia

NCT01974089

Dysphagia Pneumonia

COMPLETED

Acupuncture and Nausea/Vomiting in Pediatric Patients

NCT01417741

Postoperative Vomiting and Nausea

COMPLETED NA

Effect on Postoperative Sore Throat of Lidocaine Jelly Application Over the Endotracheal Tube of Tapered-shaped Cuff

NCT02952157

Sore Throat

UNKNOWN PHASE4

Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients

NCT03074968

Intubation Complication

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

4-test consistency, randomized, crossover, single-blinded swallow physiology study comparing effects of different liquid viscosities on swallow coordination in infants and children

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.