Clinical trial Recruiting at 1 site Observational Ages 0 Months to 12 Months

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 typeObservational
Ages0 Months to 12 Months
SexAll
Enrollment250 (estimated)
SponsorBoston Children's Hospital
Academic / other
Locations1 site (Boston, Massachusetts)
StatusRecruiting
StartedApril 1, 2021
Main results expectedAugust 31, 2027
Study endsAugust 31, 2027
Registry record updatedOctober 22, 2026
Trial IDNCT04477460 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

  • Boston Children's Hospital
    Boston, Massachusetts, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.