Effects of thickened feeds on swallowing in children with dysphagia
Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia
This study is testing if thickened liquids can help babies with swallowing problems do better when they eat.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | N/A to 21 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04504227 on ClinicalTrials.gov |
What this trial studies
This study investigates how different liquid viscosities affect swallowing physiology in infants with oropharyngeal dysphagia and brief resolved unexplained events (BRUE). It aims to quantify differences in swallowing mechanics using advanced techniques like pharyngeal high-resolution impedance manometry and videofluoroscopic swallow studies. By systematically examining the impact of thickened feedings, the research seeks to identify safe and effective interventions to improve swallowing function in affected children.
Who should consider this trial
Good fit: Ideal candidates are infants and children aged 0 to 21 years who have experienced a first lifetime BRUE or exhibit symptoms of dysphagia.
Not a fit: Patients with pre-existing conditions such as seizure disorders or congenital heart disease, or those exclusively fed by enteral tube, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved swallowing safety and reduced health complications for children with dysphagia.
How similar studies have performed: While the approach of using thickened feeds is established, this specific investigation into swallowing physiology in the context of BRUE is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Daniel R Duncan, MD, MPH — Boston Children's Hospital
- Study coordinator: Daniel R Duncan, MD, MPH
- Email: daniel.duncan@childrens.harvard.edu
- Phone: 617-355-0897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.