Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia

NCT04504227 | Recruiting DMC

• 2 other identifiers: IRB-P00036103K23DK127251
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  30 minutes

Secondary Outcomes (1)

• Impedance-Manometry Swallow Physiology Metrics

  30 minutes

Study Arms (4)

Thin liquid swallows

PLACEBO COMPARATOR

Thin liquid swallows of formula or breastmilk or other liquid

Dietary Supplement: Thin liquid swallows

Slightly thick liquid swallows

EXPERIMENTAL

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

Dietary Supplement: Slightly thickened liquid swallows

Mildly thick liquid swallows

EXPERIMENTAL

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

Dietary Supplement: Mildly thickened liquid swallows

Moderately thick liquid swallows

EXPERIMENTAL

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

Dietary Supplement: Moderately thickened liquid swallows

Interventions

Thin liquid swallows DIETARY_SUPPLEMENT

Thin liquid swallows of formula or breastmilk or other liquid

Thin liquid swallows

Slightly thickened liquid swallows DIETARY_SUPPLEMENT

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

Slightly thick liquid swallows

Mildly thickened liquid swallows DIETARY_SUPPLEMENT

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

Mildly thick liquid swallows

Moderately thickened liquid swallows DIETARY_SUPPLEMENT

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

Moderately thick liquid swallows

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 27741062 BACKGROUND

• 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.

  PMID: 31098722 BACKGROUND

• 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.

  PMID: 31103259 BACKGROUND

• 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.

  PMID: 24552674 BACKGROUND

• 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.

  PMID: 21556039 BACKGROUND

• 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.

  PMID: 36336644 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders; Brief, Resolved, Unexplained Event

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Cyanosis; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory

Study Officials

• Daniel R Duncan, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Rachel Rosen, MD, MPH

  Boston Children's Hospital

  STUDY DIRECTOR

• Sudarshan Jadcherla, MD

  Nationwide Children's Hospital

  STUDY DIRECTOR

• Taher Omari, PhD

  Flinders University

  STUDY DIRECTOR

• Samuel Nurko, MD, MPH

  Boston Children's Hospital

  STUDY DIRECTOR

Central Study Contacts

Daniel R Duncan, MD, MPH

CONTACT

617-355-0897; daniel.duncan@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: 4-test consistency, randomized, crossover, single-blinded swallow physiology study comparing effects of different liquid viscosities on swallow coordination in infants and children

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 7, 2020
• Study Start: April 1, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (1)