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

Gender

ALL

Min Age

0 Months

Max Age

12 Months

Download Date

2025-12-10

Principal Investigator

N/A

Primary Contact Information

Daniel R Duncan, MD, MPH

6173550897

daniel.duncan@childrens.harvard.edu

Intervention

Intervention Type

DIETARY_SUPPLEMENT

DIETARY_SUPPLEMENT

Intervention Name

Thickened feeds

Non-thickened feeds

Contact

For more information and to contact the study team:

Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event NCT04477460 Daniel R Duncan, MD, MPH 6173550897 daniel.duncan@childrens.harvard.edu