Effects of thickened feeds on infants with unexplained life-threatening events
Official title: Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
Run by Boston Children's Hospital · NCT04477460 · Data updated 2026-11-12
This study is trying to see if giving thicker feeds to infants who have had scary unexplained events helps improve their health and reduces the need for medical care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Months to 12 Months |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | April 1, 2021 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT04477460 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants under one year of age who have been admitted to Boston Children's Hospital after their first BRUE episode.
✕Probably not a fit
Patients with pre-existing medical conditions that exclude a BRUE diagnosis or those already receiving thickened liquids for other reasons may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates how thickened feeds impact clinical outcomes and healthcare utilization in infants who have experienced brief resolved unexplained events (BRUE). BRUE episodes can be alarming and are often associated with oropharyngeal dysphagia, which may contribute to ongoing symptoms. The study will follow a cohort of infants receiving thickened feeds compared to those on non-thickened feeds over the course of one year to assess the potential benefits of this intervention. The goal is to better understand the relationship between feeding modifications and the management of BRUE.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for infants experiencing BRUE, potentially reducing morbidity associated with these events.
How similar studies have gone: While there is limited research specifically on thickened feeds for BRUE, the study addresses a significant gap in understanding swallowing dysfunction in this population, making it a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Boston Children's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Daniel R Duncan, MD, MPH — Boston Children's Hospital
- Study coordinator: Daniel R Duncan, MD, MPH
- Email: daniel.duncan@childrens.harvard.edu
- Phone: 6173550897
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.