The 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/31103259/Actively Recruiting
Led by Boston Children's Hospital · Updated on 2026-03-18
200
Participants Needed
1
Research Sites
N/A
Total Duration
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
Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia
D
Daniel R Duncan, MD, MPH
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Boston Children's Hospital
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Progressively thickened formulas or liquids (slightly, mildly, moderately thickened) | Unthickened formula, breastmilk, or other liquids | Standard evaluation: use of videofluoroscopic swallow study, thickened liquids recommended if aspiration/risk found per guideline |
|---|---|---|---|
| What it is | Liquid swallows with increased thickness using rice cereal or Gelmix, categorized as slightly, mildly, or moderately thickened per trial protocol. | Unthickened liquids (formula, breastmilk, or other), serving as the control condition in swallow assessments. | Guideline-based approach where children with suspected dysphagia or after BRUE are evaluated by videofluoroscopic swallow study (VFSS). Thickening is recommended after VFSS if aspiration or risk is identified. |
| Role in trial | Investigational conditions to assess the effect of different degrees of thickening on swallowing safety and physiology. | Comparator condition to establish baseline swallowing function with standard (unthickened) liquids. | Represents current recommended clinical diagnostic and initial management pathway for suspected oropharyngeal dysphagia. |
| Primary use | To determine whether increasing thickness reduces aspiration during swallowing. | To provide a baseline measure of swallow risk and physiology in thin liquid consistency. | To identify the presence of aspiration and determine need for thickened liquids or other interventions. |
| How it is given or performed | Participants receive formula, breastmilk, or other liquids thickened to specific levels using rice cereal or Gelmix, consumed during a videofluoroscopic swallow study. Thickness is adjusted to protocol-specific standards (slight, mild, moderate). | Unthickened liquids (formula, breastmilk, or other) are administered during VFSS as part of the diagnostic assessment. | VFSS is performed using different liquid consistencies. If aspiration is observed on thin liquids, clinicians typically thicken liquids using agents like rice cereal or Gelmix, titrated to minimize aspiration. |
| Evidence status | Investigational evidence; results on the impact of different liquid thicknesses on swallow safety in children with aspiration risk are not yet established in published literature for this protocol. | Comparator arm within current trial; swallow risk indices and physiology with thin liquids are being measured but no final result is available. | Current practice supported by guideline and expert reviews; clinical experience shows graduated thickening can reduce aspiration risk, but exact efficacy varies by setting and patient characteristics. |
| Important limitations | Study outcomes are limited to diagnostic and physiological assessments during a brief protocol; results may not predict long-term safety or clinical feeding outcomes. | Comparator measurements focus on controlled, in-study swallow testing only and may not reflect typical feeding behavior. | While current clinical practice is informed by guideline and some evidence, thickener choice, dosing, and real-world feeding responses are variable. Long-term outcomes and safety are less well defined in literature. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor