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

  • STATUS
    Recruiting
  • End date
    Aug 31, 2025
  • participants needed
    250
  • sponsor
    Daniel Duncan
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Updated on 16 February 2024
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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).

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.

Details
Condition Esophageal Diseases, Dysphagia, Brief Resolved Unexplained Event, Apparent Life Threatening Event
Age 1years or below
Treatment Thickened feeds, Non-thickened feeds
Clinical Study IdentifierNCT04477460
SponsorDaniel Duncan
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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