An observational study in Brief Resolved Unexplained Event, Apparent Life Threatening Event and Oropharyngeal Dysphagia, sponsored by Boston Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 0 Months to 12 Months. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Boston Children's Hospital · Observational
This observational study will examine the effects of thickened feeds on clinical outcomes and healthcare utilization in infants with brief resolved unexplained event (BRUE).
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.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 250 is above the median of 84 across 249 observational studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants will be eligible for the study if they are less than 1 year of age and admitted to Boston Children's Hospital after experiencing first lifetime BRUE
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Dietary Supplement: Thickened feeds
Dietary Supplement: Non-thickened feeds
Thickened feeds directed by medical team
Non-thickened feeds directed by medical team
Frequency of persistent symptoms and repeat hospitalizations over 6-month follow-up period
Frequency of persistent symptoms and repeat hospitalizations over the 6 months after enrollment, with a comparison between those receiving and not receiving thickened feeds.
Time frame: 6 months
Frequency of persistent symptoms and hospitalization risk over the full 12-month follow-up period
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.
Time frame: 12 months
Started Apr 2021 (actual). Primary completion is estimated for Aug 2027, 76 months after the start.
Of 117 non-industry observational studies under Deglutition Disorders, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 52. This study's planned 76 months is above that.
Counting every sponsor, half of 120 studies reached it within 25 months; a quarter within 11 and three quarters within 49.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 22, 2026: primary completion Aug 2026 → Aug 2027 and completion Aug 2026 → Aug 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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