Apparent Life Threatening Event (ALTE), Aspiration, Brief Resolved Unexplained Event (BRUE), Dysphagia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTThin liquid swallows
Thin liquid swallows of formula or breastmilk or other liquid
DIETARY_SUPPLEMENTSlightly thickened liquid swallows
Slightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
DIETARY_SUPPLEMENTMildly thickened liquid swallows
Mildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
DIETARY_SUPPLEMENTModerately thickened liquid swallows
Moderately thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
Sponsors
Boston Children's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Intervention 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
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Swallow risk indices for thin vs mildly thick vs slightly thick liquids | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impedance-Manometry Swallow Physiology Metrics | 30 minutes | 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. |
Countries
United States
Contacts
CONTACTDaniel R Duncan, MD, MPH
PRINCIPAL_INVESTIGATORDaniel R Duncan, MD, MPH
Boston Children's Hospital
STUDY_DIRECTORRachel Rosen, MD, MPH
Boston Children's Hospital
STUDY_DIRECTORSudarshan Jadcherla, MD
Nationwide Children's Hospital
STUDY_DIRECTORTaher Omari, PhD
Flinders University
STUDY_DIRECTORSamuel Nurko, MD, MPH
Boston Children's Hospital
Outcome results
None listed