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
Min Age
0 Months
Max Age
12 Months
Download Date
April 19, 2024
Principal Investigator
Daniel Duncan
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: