Oropharyngeal Dysphagia Is Strongly Correlated With Apparent Life-Threatening Events.
Daniel R Duncan, Janine Amirault, Paul D Mitchell...
https://pubmed.ncbi.nlm.nih.gov/27741062Actively Recruiting
Phase Not Applicable
Age: 0 - 21Years
All Genders
ID04504227
Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia
Led by Boston Children's Hospital · Updated on 2026-03-18
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Boston Children's Hospital
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of different liquid thickness levels on swallowing function in infants and children with oropharyngeal dysphagia, including those who have experienced brief resolved unexplained events (BRUE). These swallowing problems can cause symptoms like choking and cyanosis, and the study aims to better understand the swallowing physiology and how it relates to these symptoms by using advanced swallowing tests. Participants will be randomly assigned to swallow various liquids with different viscosities: thin liquids like formula or breastmilk, and liquids thickened slightly, mildly, or moderately using rice cereal or Gelmix. The study compares how these different thicknesses affect swallowing safety and function through detailed physiology measurements, including videofluoroscopic swallow studies and pharyngeal high resolution impedance-manometry. During the study, participants will undergo swallow tests lasting about 30 minutes to measure swallow risk indices and other swallow physiology metrics. Researchers will monitor swallowing function carefully and assess how different liquid thicknesses influence outcomes. The study includes children from birth up to 21 years old, and participation involves clinical assessments to track swallow safety and possible improvements with thickened feeds.
CONDITIONS
Brief Title
Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia
Who Can Participate
Age: 0 - 21Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 0 to 21 years
- Admitted to Boston Children's Hospital after first lifetime BRUE or with dysphagia symptoms placing at risk for BRUE or swallowing difficulty
- Have had or might have a videofluoroscopic swallow study performed
You will not qualify if you...
- Pre-existing diagnoses excluding BRUE such as seizure disorders and cyanotic congenital heart disease
- Nasal, pharyngeal, or esophageal anomalies affecting safe catheter placement
- Children fed exclusively by enteral tube
- Allergy to rice cereal or Gelmix thickener used in the study liquids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Approximately 30 minutes
Participants undergo detailed swallow physiology studies using pharyngeal high resolution impedance-manometry and videofluoroscopic swallow study to assess swallowing function.
1 visit (in-person)
Treatment
Duration - Crossover design with multiple short exposures during study visits
Participants receive different liquid thickness interventions including thin, slightly thick, mildly thick, and moderately thickened liquid swallows to evaluate effects on swallow physiology.
1 or more visits depending on crossover schedule
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
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Research Team
D
Daniel R Duncan, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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Published Research Related To This Trial
Clinical Aspects of Thickeners for Pediatric Gastroesophageal Reflux and Oropharyngeal Dysphagia.
Daniel R Duncan, Kara Larson, Rachel L Rosen
https://pubmed.ncbi.nlm.nih.gov/31098722The Impact of the American Academy of Pediatrics Brief Resolved Unexplained Event Guidelines on Gastrointestinal Testing and Prescribing Practices.
Daniel R Duncan, Amanda S Growdon, Enju Liu...
https://pubmed.ncbi.nlm.nih.gov/31103259Objective assessment of swallow function in children with suspected aspiration using pharyngeal automated impedance manometry.
Nathalie Rommel, Margot Selleslagh, Ilse Hoffman...
https://pubmed.ncbi.nlm.nih.gov/24552674A novel method for the nonradiological assessment of ineffective swallowing.
Taher I Omari, Eddy Dejaeger, Dirk Van Beckevoort...
https://pubmed.ncbi.nlm.nih.gov/21556039A Prospective Study of Brief Resolved Unexplained Events: Risk Factors for Persistent Symptoms.
Daniel R Duncan, Enju Liu, Amanda S Growdon...
https://pubmed.ncbi.nlm.nih.gov/36336644