NCT04504227 Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia
| NCT ID | NCT04504227 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Children's Hospital |
| Condition | Dysphagia |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2021-04-01 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Daniel R Duncan, MD, MPH
PRINCIPAL INVESTIGATOR
Boston Children's Hospital
Frequently Asked Questions
Who can join the NCT04504227 clinical trial?
This trial is open to participants of all sexes, up to 21 Years, studying Dysphagia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04504227 currently recruiting?
Yes, NCT04504227 is actively recruiting participants. Contact the research team at daniel.duncan@childrens.harvard.edu for enrollment information.
Where is the NCT04504227 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04504227 clinical trial?
NCT04504227 is sponsored by Boston Children's Hospital. The principal investigator is Daniel R Duncan, MD, MPH at Boston Children's Hospital. The trial plans to enroll 200 participants.