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Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04477460
Study type Observational
Source Boston Children's Hospital
Contact Daniel R Duncan, MD, MPH
Phone 6173550897
Email daniel.duncan@childrens.harvard.edu
Status Recruiting
Phase
Start date April 1, 2021
Completion date August 31, 2025

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