---
title: Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
nct_id: NCT04477460
overall_status: RECRUITING
sponsor: "Boston Children's Hospital"
study_type: OBSERVATIONAL
primary_condition: Brief Resolved Unexplained Event
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04477460.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04477460"
ct_last_update_post_date: 2026-03-18
last_seen_at: "2026-05-12T06:09:55.786Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event

**NCT ID:** [NCT04477460](https://clinicaltrials.gov/study/NCT04477460)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 250
- **Lead Sponsor:** Boston Children's Hospital
- **Collaborators:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- **Conditions:** Brief Resolved Unexplained Event, Apparent Life Threatening Event, Oropharyngeal Dysphagia
- **Start Date:** 2021-04-01
- **Completion Date:** 2026-08-31
- **CT.gov Last Update:** 2026-03-18

## 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.

## Eligibility

- **Minimum age:** 0 Months
- **Maximum age:** 12 Months
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Infants with BRUE receiving thickened feeds**
- **Infants with BRUE not receiving thickened feeds**

## Interventions

- **Thickened feeds** (DIETARY_SUPPLEMENT) — Thickened feeds directed by medical team
- **Non-thickened feeds** (DIETARY_SUPPLEMENT) — Non-thickened feeds directed by medical team

## Primary Outcomes

- **Frequency of persistent symptoms and repeat hospitalizations over 6-month follow-up period** _(time frame: 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 Outcomes

- **Frequency of persistent symptoms and hospitalization risk over the full 12-month follow-up period** _(time frame: 12 months)_

## Locations (1)

- Boston Children's Hospital, Boston, Massachusetts, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.boston children's hospital|boston|massachusetts|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04477460.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04477460*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*