DysphagiaNCT04504227
Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia
A study testing Thin liquid swallows, Slightly thickened liquid swallows and Mildly thickened liquid swallows in people with Dysphagia and Aspiration, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Dysphagia, Aspiration, Brief Resolved Unexplained Event (BRUE)
- What is being tested?
- Thin liquid swallows, Slightly thickened liquid swallows and Mildly thickened liquid swallows
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Daniel R Duncan, MD, MPH, 6173550897, daniel.duncan@childrens.harvard.edu
About this study
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.
Read the 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.
- Conditions
- Dysphagia, Aspiration, Brief Resolved Unexplained Event (BRUE), Apparent Life Threatening Event (ALTE)
- Being tested
- Thin liquid swallows, Slightly thickened liquid swallows, Mildly thickened liquid swallows, Moderately thickened liquid swallows
- Medical subject headings
- Deglutition Disorders, Brief, Resolved, Unexplained Event
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thin liquid swallowsDietary supplement
Thin liquid swallows of formula or breastmilk or other liquid
Slightly thickened liquid swallowsDietary supplement
Slightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
Mildly thickened liquid swallowsDietary supplement
Mildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
Moderately thickened liquid swallowsDietary supplement
Moderately thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
| Study group | Role | What they receive |
|---|---|---|
| Thin liquid swallows | Placebo comparator | Thin liquid swallows of formula or breastmilk or other liquid Receives: 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: Moderately thickened liquid swallows |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (1)
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Apr 2021
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Duncan, Boston Children's Hospital
- Investigators
- Daniel R Duncan, MD, MPH, Principal investigator, Boston Children's HospitalRachel Rosen, MD, MPH, Study director, Boston Children's HospitalSudarshan Jadcherla, MD, Study director, Nationwide Children's HospitalTaher Omari, PhD, Study director, Flinders UniversitySamuel Nurko, MD, MPH, Study director, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504227
- Sponsor's protocol ID
- IRB-P00036103
- Other IDs
- K23DK127251
- Status last verified
- Mar 2026
- First submitted
- 5 Aug 2020
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27741062Duncan 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.
PubMed 31098722Duncan 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.
PubMed 31103259Rommel 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.
PubMed 24552674Omari 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.
PubMed 21556039Duncan 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.
PubMed 36336644
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia
- ClinicalTrials.gov ID
- NCT04504227
- Acronym / sponsor ID
- IRB-P00036103
- Conditions
- Dysphagia, Aspiration, Brief Resolved Unexplained Event (BRUE), Apparent Life Threatening Event (ALTE)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Thin liquid swallows | Placebo comparator | Dietary Supplement: Thin liquid swallowsThin liquid swallows of formula or breastmilk or other liquid |
| Slightly thick liquid swallows | Experimental | Dietary Supplement: Slightly thickened liquid swallowsSlightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix |
| Mildly thick liquid swallows | Experimental | Dietary Supplement: Mildly thickened liquid swallowsMildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix |
| Moderately thick liquid swallows | Experimental | Dietary Supplement: Moderately thickened liquid swallowsModerately thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thin liquid swallowsThin liquid swallows of formula or breastmilk or other liquid | Dietary supplement | Thin liquid swallows |
| Slightly thickened liquid swallowsSlightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix | Dietary supplement | Slightly thick liquid swallows |
| Mildly thickened liquid swallowsMildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix | Dietary supplement | Mildly thick liquid swallows |
| Moderately thickened liquid swallowsModerately thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix | Dietary supplement | Moderately thick liquid swallows |
Primary outcome
Swallow risk indices for thin vs mildly thick vs slightly thick liquids
Time frame: 30 minutes
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.
1 secondary outcome
Impedance-Manometry Swallow Physiology Metrics
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 27741062Duncan 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.
- Background: PubMed 31098722Duncan 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.
- Background: PubMed 31103259Duncan 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.
- Background: PubMed 24552674Rommel 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.
- Background: PubMed 21556039Omari 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.
- Background: PubMed 36336644Duncan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thin liquid swallows, Slightly thickened liquid swallows and Mildly thickened liquid swallows in people with Dysphagia and Aspiration, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel R Duncan, MD, MPH (617-355-0897, daniel.duncan@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallow risk indices for thin vs mildly thick vs slightly thick liquids (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04504227, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.