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Observational Study of Thickened Feeds for Infants with Brief Resolved Unexplained Event (BRUE)

This study is looking at how thickened feeds affect infants who have experienced a Brief Resolved Unexplained Event (BRUE). A BRUE is a scary episode where an infant might suddenly stop breathing, turn pale or blue, or become limp. Researchers want to see if giving infants thickened feeds, compared to regular feeds, changes how often they have ongoing symptoms or need to be hospitalized again. They will follow about 250 infants for 6 months to track these outcomes. You might be able to join if your infant is less than 1 year old, has had their first BRUE, and is admitted to Boston Children's Hospital. Infants with certain pre-existing medical conditions or who are already on thickened liquids for another reason cannot participate.

Study design
This is an observational study, meaning researchers will watch what happens to infants who receive thickened feeds versus those who don't, rather than assigning treatments. It aims to include about 250 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months to track the frequency of persistent symptoms and repeat hospitalizations.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04477460

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

Recruiting
Not specifiedAges 0–12Observational
Boston Children's Hospital
~250 participants
Updated 2026-03-18 on ClinicalTrials.gov
What's tested:Thickened feedsNon-thickened feeds

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of persistent symptoms and repeat hospitalizations over 6-month follow-up period
Measured over 6 months

Conditions

Brief Resolved Unexplained Event
Apparent Life Threatening Event
Oropharyngeal Dysphagia

Explore related trials

Apparent Life Threatening EventBrief resolved unexplained eventOropharyngeal Dysphagia

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Daniel R Duncan, MD, MPH · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital
  • Rachel Rosen, MD, MPH · STUDY_DIRECTOR · Boston Children's Hospital
  • Sudarshan Jadcherla, MD · STUDY_DIRECTOR · Nationwide Children's Hospital
  • Taher Omari, PhD · STUDY_DIRECTOR · Flinders University
  • Samuel Nurko, MD, MPH · STUDY_DIRECTOR · Boston Children's Hospital

Who to contact

Daniel R Duncan, MD, MPH
[email protected]
6173550897
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Less than 1 year of age
Admitted to Boston Children's Hospital after experiencing first lifetime brief resolved unexplained event.

Exclusion

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

What this trial measures

  • Frequency of persistent symptoms and repeat hospitalizations over 6-month follow-up period6 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.