NCT04477460

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 0 Months – 12 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Brief Resolved Unexplained Event
• Apparent Life Threatening Event
• Oropharyngeal Dysphagia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Thickened feeds	Thickened feeds directed by medical team
DIETARY_SUPPLEMENT	Non-thickened feeds	Non-thickened feeds directed by medical team

Timeline

• Start date: 2021-04-01
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2020-07-20
• Last updated: 2026-03-18

Locations

1 site across 1 country: United States