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

Recruiting

• Conditions: Oropharyngeal Dysphagia; Apparent Life Threatening Event; Brief Resolved Unexplained Event
• Interventions: Dietary Supplement: Thickened feeds; Dietary Supplement: Non-thickened feeds

• Registration Number: NCT04477460
• Lead Sponsor: Boston Children's Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-20
• Study Start: 2021-04-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infants with BRUE receiving thickened feeds	Thickened feeds	-
Infants with BRUE not receiving thickened feeds	Non-thickened feeds	-

Primary Outcome Measures

Name	Time	Method
Frequency of persistent symptoms and repeat hospitalizations over 6-month follow-up period	6 months	Frequency of persistent symptoms and repeat hospitalizations over the 6 months after enrollment, with a comparison between those receiving and not receiving thickened feeds.

Secondary Outcome Measures

Name	Time	Method
Frequency of persistent symptoms and hospitalization risk over the full 12-month follow-up period	12 months	Symptoms and hospitalization risk over the full 12-month follow-up period, optimal period of time needed for thickening, parent-reported anxiety levels, cost of care at Boston Children's Hospital, potential adverse effects of thickening, and urine arsenic levels, all compared between subjects receiving and not receiving thickened feeds.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States