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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes

Awards & highlights

Study Summary

This trial will study how different thicknesses of liquids affect swallowing in infants with dysphagia or other conditions that put them at risk for 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.Check my eligibility

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.See study design

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 below

Select...

I am 21 years old or younger.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Swallow risk indices for thin vs mildly thick vs slightly thick liquids

Secondary outcome measures

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

761 Previous Clinical Trials

5,579,530 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,315,295 Total Patients Enrolled

Sudarshan Jadcherla, MDStudy DirectorNationwide Children's Hospital

1 Previous Clinical Trials

250 Total Patients Enrolled

Media Library

Thickened Feeds Clinical Trial Eligibility Overview. Trial Name: NCT04504227 — N/A

Swallowing Difficulty Research Study Groups: Mildly thick liquid swallows, Slightly thick liquid swallows, Thin liquid swallows, Moderately thick liquid swallows

Swallowing Difficulty Clinical Trial 2023: Thickened Feeds Highlights & Side Effects. Trial Name: NCT04504227 — N/A

Thickened Feeds 2023 Treatment Timeline for Medical Study. Trial Name: NCT04504227 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this research endeavor still open?

"Affirmative. Data published on clinicaltrials.gov reveals that this research is currently recruiting, first posted on April 1st 2021 and last modified on July 18th 2022. The investigation seeks to find 200 participants from a single location."

Answered by AI

Could I possibly join this medical research project?

"This dysphagia trial is accepting 200 patients between infancy and 21 years of age that have been admitted to Boston Children's Hospital with a first-time BRUE, or symptoms indicating the potential for such an event."

Answered by AI

Is this trial accepting elderly participants?

"The inclusion criteria for this medical trial necessitates that participants be between 0 Months and 21 years of age. Subsequently, there are 8 studies available to minors as well as a separate cohort of 73 trials specifically for seniors over 65."

Answered by AI

How many participants are being accepted into the experiment?

"Affirmative, this clinical trial is actively seeking participants. The initial post was published on April 1st 2021 and the information has since been revised as recently as July 18th 2022. This medical research aims to recruit 200 people from a single site."

Answered by AI

Recent research and studies

Journal of Pediatric Gastroenterology & NutritionJournal

Objective Assessment of Swallow Function in Children with Suspected Aspiration Using Pharyngeal Automated Impedance Manometry

Rommel, Nathalie, Margot Selleslagh, Ilse Hoffman, Maria H. Smet, Geoffrey Davidson, Jan Tack, and Taher Imad Omari. 2014. “Objective Assessment of Swallow Function in Children with Suspected Aspiration Using Pharyngeal Automated Impedance Manometry”. Journal of Pediatric Gastroenterology & Nutrition. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mpg.0000000000000337.

Current Gastroenterology ReportsJournal

Clinical Aspects of Thickeners for Pediatric Gastroesophageal Reflux and Oropharyngeal Dysphagia

Duncan, Daniel R., Kara Larson, and Rachel L. Rosen. 2019. “Clinical Aspects of Thickeners for Pediatric Gastroesophageal Reflux and Oropharyngeal Dysphagia”. Current Gastroenterology Reports. Springer Science and Business Media LLC. doi:10.1007/s11894-019-0697-2.

The Journal of PediatricsJournal

The Impact of the American Academy of Pediatrics Brief Resolved Unexplained Event Guidelines on Gastrointestinal Testing and Prescribing Practices

Duncan, Daniel R., Amanda S. Growdon, Enju Liu, Kara Larson, Madeline Gonzalez, Kerri Norris, and Rachel L. Rosen. 2019. “The Impact of the American Academy of Pediatrics Brief Resolved Unexplained Event Guidelines on Gastrointestinal Testing and Prescribing Practices”. The Journal of Pediatrics. Elsevier BV. doi:10.1016/j.jpeds.2019.04.007.

Journal of Pediatric Gastroenterology & NutritionJournal