Current Environment:

Summary

This observational study will examine the effects of thickened feeds on clinical outcomes and healthcare utilization in infants with brief resolved unexplained event (BRUE).

Conditions

Brief Resolved Unexplained Event, Apparent Life Threatening Event, Oropharyngeal Dysphagia

Recruitment Status

Recruiting

Detailed Description

Brief resolved unexplained events (BRUE) are frightening episodes characterized by the appearance of life-threatening choking, pallor, cyanosis, and limpness in infants. These common events are resource-intensive and current management approaches inadequately address persistent symptoms. Infants with BRUE commonly have oropharyngeal dysphagia with aspiration, which is a modifiable risk factor for persistent symptoms, but there are no studies determining the mechanism behind this swallowing dysfunction and if swallowing interventions reduce morbidity. This is a prospective, longitudinal cohort study of infants who experienced brief resolved unexplained event receiving thickened feedings compared to those not receiving thickened feedings over 1 year.

Eligibility Criteria

Inclusion Criteria:

Less than 1 year of age
Admitted to Boston Children's Hospital after experiencing first lifetime brief resolved unexplained event.

Exclusion Criteria:

Any pre-existing medical diagnoses that exclude brief resolved unexplained event diagnosis including seizure disorders and cyanotic congenital heart disease
Already receiving thickened liquids for treatment of another condition

Intervention

Intervention Type

Intervention Name

Dietary Supplement

Thickened feeds

Dietary Supplement

Non-thickened feeds

Gender

All

Minimum Age

N/A

Maximum Age

12 Months

Download Date

July 27, 2021

Principal Investigator

Daniel Duncan

Primary Contact Information

Daniel R Duncan, MD, MPH

6173550897

daniel.duncan@childrens.harvard.edu

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: