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Search / Trial NCT04477460

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

Launched by BOSTON CHILDREN'S HOSPITAL · Jul 15, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how thickened feeds—foods or liquids that have been made thicker—can affect the health and wellbeing of infants who have experienced a Brief Resolved Unexplained Event (BRUE). A BRUE is when a baby suddenly has a scary episode, like trouble breathing or turning blue, but then quickly gets better and shows no lasting problems. The study will focus on babies less than one year old who were admitted to Boston Children’s Hospital after their first BRUE.

To participate, infants must be under one year of age and should not have any other serious health issues, like seizure disorders or certain heart conditions. The trial is currently recruiting participants, and families involved can expect to help researchers understand if thickened feeds can improve outcomes for these infants. This could potentially lead to better care for babies with similar events in the future.

Gender

ALL

Eligibility 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

About Boston Children's Hospital

Boston Children's Hospital is a leading pediatric healthcare institution renowned for its commitment to advancing child health through innovative research and exceptional clinical care. As a prominent clinical trial sponsor, the hospital leverages its extensive expertise in pediatric medicine to conduct rigorous and ethically sound research studies aimed at improving treatment options and outcomes for children. With a collaborative approach that integrates cutting-edge technology and multidisciplinary teams, Boston Children's Hospital is dedicated to translating scientific discoveries into practical applications that enhance the well-being of young patients and their families.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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