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

Boston Children's Hospital

Status

Enrolling

Conditions

Brief Resolved Unexplained Event

Oropharyngeal Dysphagia

Apparent Life Threatening Event

Treatments

Dietary Supplement: Thickened feeds

Dietary Supplement: Non-thickened feeds

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT04477460

K23DK127251 (U.S. NIH Grant/Contract)

IRB-P00038785

Details and patient eligibility

About

This observational study will examine the effects of thickened feeds on clinical outcomes and healthcare utilization in infants with brief resolved unexplained event (BRUE).

Full 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.

Enrollment

250 estimated patients

Sex

All

Ages

Under 12 months old

Volunteers

No Healthy Volunteers

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