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Thickened Feeds for Swallowing Disorders
N/A
Recruiting
Led By Daniel R Duncan, MD, MPH
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 0 to 21 years
Be younger than 65 years old
Must not have
Any nasal/pharyngeal/esophageal anomalies that might affect safe placement of the pharyngeal motility catheter
Children fed exclusively by enteral tube
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
Summary
This trial will test if thickening baby formula can help infants who have trouble swallowing. The study focuses on infants with swallowing issues and unexplained choking episodes. Thicker liquids are easier to swallow and may reduce choking risks. Thicker liquids are often recommended to reduce the risk of swallowing problems.
Who is the study for?
This trial is for children aged 0 to 21 years who have swallowing difficulties, specifically those admitted to Boston Children's Hospital after a first BRUE or at risk for swallow dysfunction. It excludes kids fed only by tubes, with certain nasal/pharyngeal/esophageal anomalies, pre-existing conditions like seizures or heart disease, and allergies to specific thickeners.
What is being tested?
The study tests how different thicknesses of liquids affect the way infants and children with dysphagia swallow. Participants will try swallows of mildly thickened, thin, moderately thickened, and slightly thickened liquids while their swallow physiology is observed.
What are the potential side effects?
While not explicitly stated in the provided information, potential side effects may include discomfort from swallowing difficulties when testing various liquid viscosities and any reactions related to allergy if exposed inadvertently to allergens.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or younger.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have no issues with my nose, throat, or esophagus that could complicate catheter placement.
Select...
My child is fed only through a feeding tube.
Select...
I do not have a history of seizures or certain heart diseases.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Swallow risk indices for thin vs mildly thick vs slightly thick liquids
Secondary study objectives
Impedance-Manometry Swallow Physiology Metrics
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Slightly thick liquid swallowsExperimental Treatment1 Intervention
Slightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
Group II: Moderately thick liquid swallowsExperimental Treatment1 Intervention
Moderately thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
Group III: Mildly thick liquid swallowsExperimental Treatment1 Intervention
Mildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
Group IV: Thin liquid swallowsPlacebo Group1 Intervention
Thin liquid swallows of formula or breastmilk or other liquid
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for swallowing difficulty, particularly those involving liquid viscosity, include thickened liquids and modified diets. Thickened liquids work by slowing down the flow of liquids, giving patients more control over the swallowing process and reducing the risk of aspiration.
This is crucial for patients with dysphagia as it helps prevent food or liquid from entering the airway, which can lead to pneumonia or other respiratory complications. By altering the thickness of liquids, these treatments improve swallow safety and efficiency, making it easier for patients to consume necessary nutrients and maintain hydration.
Find a Location
Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
781 Previous Clinical Trials
5,580,931 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,428 Previous Clinical Trials
4,322,531 Total Patients Enrolled
Taher Omari, PhDStudy DirectorFlinders University
1 Previous Clinical Trials
250 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 21 years old or younger.I have no issues with my nose, throat, or esophagus that could complicate catheter placement.I was admitted to Boston Children's Hospital for a first-time BRUE or because I have trouble swallowing.I have had or may have a swallow study with video.My child is fed only through a feeding tube.I do not have a history of seizures or certain heart diseases.
Research Study Groups:
This trial has the following groups:- Group 1: Mildly thick liquid swallows
- Group 2: Slightly thick liquid swallows
- Group 3: Thin liquid swallows
- Group 4: Moderately thick liquid swallows
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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