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NCT04477460Recruiting

Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event

Boston Children's Hospital

Start Date

4/1/2021

Completion Date

8/31/2026

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).

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

Age Range: No minimum to No maximum

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

Interventions

DIETARY_SUPPLEMENT

Thickened feeds

DIETARY_SUPPLEMENT

Non-thickened feeds

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Conditions

Brief Resolved Unexplained EventApparent Life Threatening EventOropharyngeal Dysphagia

Locations

Boston Children's Hospital

Boston, Massachusetts 02115

United States