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Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

Primary Purpose

Dysphagia, Aspiration, Brief Resolved Unexplained Event (BRUE)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thin liquid swallows
Slightly thickened liquid swallows
Mildly thickened liquid swallows
Moderately thickened liquid swallows
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dysphagia

Eligibility Criteria

0 Months - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Thin liquid swallows

Slightly thick liquid swallows

Mildly thick liquid swallows

Moderately thick liquid swallows

Arm Description

Thin liquid swallows of formula or breastmilk or other liquid

Slightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix

Mildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix

Moderately thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix

Outcomes

Primary Outcome Measures

Swallow risk indices for thin vs mildly thick vs slightly thick liquids
We will calculate swallow risk index (SRI) from impedance-manometry results to compare mean SRI with thin liquids and thickened liquids for subjects with aspiration compared to mean SRI for thin liquids and thickened liquids in subjects without aspiration.

Secondary Outcome Measures

Impedance-Manometry Swallow Physiology Metrics
We will measure swallow physiology metrics from impedance-manometry results, including post-swallow impedance ratio, to compare these parameters with thin liquids between subjects with and without aspiration and with varied liquid consistencies within subjects.

Full Information

First Posted
August 5, 2020
Last Updated
June 20, 2023
Sponsor
Boston Children's Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04504227
Brief Title
Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia
Official Title
Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Infants with oropharyngeal dysphagia and in particular brief resolved unexplained events (BRUE) are a significant driver of pediatric health care expenditure since the mechanism for their swallow dysfunction is incompletely understood and therefore frequently goes unrecognized and untreated. We hypothesize that infants with oropharyngeal dysphagia and BRUE have measurable differences in swallowing physiology to explain their symptoms of cyanotic choking spells, that these differences can be quantified using pharyngeal high resolution impedance-manometry compared to videofluoroscopic swallow study results, and that this swallowing dysfunction can be safely corrected with a change of formula viscosity. Through this research project, we will systematically investigate the effects of thickened feedings on swallow function in infants with dysphagia and BRUE and perform detailed physiology studies on pharyngeal and esophageal motility as critical mediators of improved outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Aspiration, Brief Resolved Unexplained Event (BRUE), Apparent Life Threatening Event (ALTE)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
4-test consistency, randomized, crossover, single-blinded swallow physiology study comparing effects of different liquid viscosities on swallow coordination in infants and children
Masking
Investigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thin liquid swallows
Arm Type
Placebo Comparator
Arm Description
Thin liquid swallows of formula or breastmilk or other liquid
Arm Title
Slightly thick liquid swallows
Arm Type
Experimental
Arm Description
Slightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
Arm Title
Mildly thick liquid swallows
Arm Type
Experimental
Arm Description
Mildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
Arm Title
Moderately thick liquid swallows
Arm Type
Experimental
Arm Description
Moderately thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
Intervention Type
Dietary Supplement
Intervention Name(s)
Thin liquid swallows
Intervention Description
Thin liquid swallows of formula or breastmilk or other liquid
Intervention Type
Dietary Supplement
Intervention Name(s)
Slightly thickened liquid swallows
Intervention Description
Slightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
Intervention Type
Dietary Supplement
Intervention Name(s)
Mildly thickened liquid swallows
Intervention Description
Mildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
Intervention Type
Dietary Supplement
Intervention Name(s)
Moderately thickened liquid swallows
Intervention Description
Moderately thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
Primary Outcome Measure Information:
Title
Swallow risk indices for thin vs mildly thick vs slightly thick liquids
Description
We will calculate swallow risk index (SRI) from impedance-manometry results to compare mean SRI with thin liquids and thickened liquids for subjects with aspiration compared to mean SRI for thin liquids and thickened liquids in subjects without aspiration.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Impedance-Manometry Swallow Physiology Metrics
Description
We will measure swallow physiology metrics from impedance-manometry results, including post-swallow impedance ratio, to compare these parameters with thin liquids between subjects with and without aspiration and with varied liquid consistencies within subjects.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel R Duncan, MD, MPH
Phone
617-355-0897
Email
daniel.duncan@childrens.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel R Duncan, MD, MPH
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rachel Rosen, MD, MPH
Organizational Affiliation
Boston Children's Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sudarshan Jadcherla, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Taher Omari, PhD
Organizational Affiliation
Flinders University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Samuel Nurko, MD, MPH
Organizational Affiliation
Boston Children's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel R Duncan, MD, MPH
Phone
617-355-0897
Email
daniel.duncan@childrens.harvard.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
27741062
Citation
Duncan DR, Amirault J, Mitchell PD, Larson K, Rosen RL. Oropharyngeal Dysphagia Is Strongly Correlated With Apparent Life-Threatening Events. J Pediatr Gastroenterol Nutr. 2017 Aug;65(2):168-172. doi: 10.1097/MPG.0000000000001439.
Results Reference
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PubMed Identifier
31098722
Citation
Duncan DR, Larson K, Rosen RL. Clinical Aspects of Thickeners for Pediatric Gastroesophageal Reflux and Oropharyngeal Dysphagia. Curr Gastroenterol Rep. 2019 May 16;21(7):30. doi: 10.1007/s11894-019-0697-2.
Results Reference
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PubMed Identifier
31103259
Citation
Duncan DR, Growdon AS, Liu E, Larson K, Gonzalez M, Norris K, Rosen RL. The Impact of the American Academy of Pediatrics Brief Resolved Unexplained Event Guidelines on Gastrointestinal Testing and Prescribing Practices. J Pediatr. 2019 Aug;211:112-119.e4. doi: 10.1016/j.jpeds.2019.04.007. Epub 2019 May 15.
Results Reference
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PubMed Identifier
24552674
Citation
Rommel N, Selleslagh M, Hoffman I, Smet MH, Davidson G, Tack J, Omari TI. Objective assessment of swallow function in children with suspected aspiration using pharyngeal automated impedance manometry. J Pediatr Gastroenterol Nutr. 2014 Jun;58(6):789-94. doi: 10.1097/MPG.0000000000000337.
Results Reference
background
PubMed Identifier
21556039
Citation
Omari TI, Dejaeger E, Van Beckevoort D, Goeleven A, De Cock P, Hoffman I, Smet MH, Davidson GP, Tack J, Rommel N. A novel method for the nonradiological assessment of ineffective swallowing. Am J Gastroenterol. 2011 Oct;106(10):1796-802. doi: 10.1038/ajg.2011.143. Epub 2011 May 10.
Results Reference
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PubMed Identifier
36336644
Citation
Duncan DR, Liu E, Growdon AS, Larson K, Rosen RL. A Prospective Study of Brief Resolved Unexplained Events: Risk Factors for Persistent Symptoms. Hosp Pediatr. 2022 Dec 1;12(12):1030-1043. doi: 10.1542/hpeds.2022-006550.
Results Reference
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Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

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