RECRUITING

Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

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Conditions

DysphagiaAspirationBrief Resolved Unexplained Event (BRUE)Apparent Life Threatening Event (ALTE)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

Quick Facts

Study Start:2021-04-01
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04504227

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 0 to 21 years
  2. * 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
  3. * Have had videofluoroscopic swallow study performed or might have future videofluoroscopic swallow study performed.
  1. * Any pre-existing medical diagnoses that exclude brief resolved unexplained event diagnosis including seizure disorders and cyanotic congenital heart disease
  2. * Any nasal/pharyngeal/esophageal anomalies that might affect safe placement of the pharyngeal motility catheter
  3. * Children fed exclusively by enteral tube
  4. * Allergy to rice cereal or Gelmix thickener, which will be used to adjust liquid viscosity

Contacts and Locations

Study Contact

Daniel R Duncan, MD, MPH
CONTACT
617-355-0897
daniel.duncan@childrens.harvard.edu

Principal Investigator

Daniel R Duncan, MD, MPH
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Rachel Rosen, MD, MPH
STUDY_DIRECTOR
Boston Children's Hospital
Sudarshan Jadcherla, MD
STUDY_DIRECTOR
Nationwide Children's Hospital
Taher Omari, PhD
STUDY_DIRECTOR
Flinders University
Samuel Nurko, MD, MPH
STUDY_DIRECTOR
Boston Children's Hospital

Study Locations (Sites)

Boston Children's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

  • Daniel R Duncan, MD, MPH, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital
  • Rachel Rosen, MD, MPH, STUDY_DIRECTOR, Boston Children's Hospital
  • Sudarshan Jadcherla, MD, STUDY_DIRECTOR, Nationwide Children's Hospital
  • Taher Omari, PhD, STUDY_DIRECTOR, Flinders University
  • Samuel Nurko, MD, MPH, STUDY_DIRECTOR, Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-01
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2021-04-01
Study Completion Date2025-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Dysphagia
  • Aspiration
  • Brief Resolved Unexplained Event (BRUE)
  • Apparent Life Threatening Event (ALTE)