Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 50
Summary
- Conditions
- Apparent Life Threatening Event (ALTE)
- Aspiration
- Brief Resolved Unexplained Event (BRUE)
- Dysphagia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: 4-test consistency, randomized, crossover, single-blinded swallow physiology study comparing effects of different liquid viscosities on swallow coordination in infants and childrenMasking: Single (Investigator)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Younger than 21 years
- Gender
- Both males and females
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 hypo...
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.
Tracking Information
- NCT #
- NCT04504227
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Investigators
- Principal Investigator: Daniel R Duncan, MD, MPH Boston Children's Hospital Study Director: Rachel Rosen, MD, MPH Boston Children's Hospital Study Director: Sudarshan Jadcherla, MD Nationwide Children's Hospital Study Director: Taher Omari, PhD Flinders University Study Director: Samuel Nurko, MD, MPH Boston Children's Hospital
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