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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK127251 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thin liquid swallows | Placebo Comparator | Thin liquid swallows of formula or breastmilk or other liquid |
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| Slightly thick liquid swallows | Experimental | Slightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix |
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| Mildly thick liquid swallows | Experimental | Mildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix |
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| Moderately thick liquid swallows | Experimental | Moderately thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thin liquid swallows | Dietary Supplement | Thin liquid swallows of formula or breastmilk or other liquid |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel R Duncan, MD, MPH | Contact | 617-355-0897 | daniel.duncan@childrens.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Daniel R Duncan, MD, MPH | Boston Children's Hospital | Principal Investigator |
| Rachel Rosen, MD, MPH | Boston Children's Hospital | Study Director |
| Sudarshan Jadcherla, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27741062 | Background | 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. | |
| 31098722 | 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. |
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4-test consistency, randomized, crossover, single-blinded swallow physiology study comparing effects of different liquid viscosities on swallow coordination in infants and children
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| Slightly thickened liquid swallows | Dietary Supplement | Slightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix |
|
| Mildly thickened liquid swallows | Dietary Supplement | Mildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix |
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| Moderately thickened liquid swallows | Dietary Supplement | Moderately thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix |
|
| Nationwide Children's Hospital |
| Study Director |
| Taher Omari, PhD | Flinders University | Study Director |
| Samuel Nurko, MD, MPH | Boston Children's Hospital | Study Director |
| 31103259 | 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. |
| 24552674 | 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. |
| 21556039 | 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. |
| 36336644 | 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. |
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D057768 | Brief, Resolved, Unexplained Event |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D003490 | Cyanosis |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
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