Status:
RECRUITING
Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Brief Resolved Unexplained Event
Apparent Life Threatening Event
Eligibility:
All Genders
Up to 12 years
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 resour...
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
Key Trial Info
Start Date :
April 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04477460
Start Date
April 1 2021
End Date
August 31 2026
Last Update
December 10 2025
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115