RecruitingNCT04477460
Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
Sponsor
Boston Children's Hospital
Enrollment
250 participants
Start Date
Apr 1, 2021
Study Type
OBSERVATIONAL
Conditions
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).
Eligibility
Min Age: 0 MonthsMax Age: 12 Months
Plain Language Summary
Simplified for easier understanding
This study follows infants who experienced a Brief Resolved Unexplained Event (BRUE) — a sudden and frightening episode involving choking, color change, limpness, or breathing difficulty — to see whether thickening their feeds reduces future episodes and healthcare use. BRUEs are common in infancy but poorly understood, and swallowing difficulties may play a role. Infants under 1 year of age who are admitted to Boston Children's Hospital after their first-ever BRUE may be eligible, unless they have a pre-existing condition such as a seizure disorder or congenital heart disease. Participation involves following the infant's feeding and health outcomes over 1 year, with some infants receiving thickened feeds and others receiving standard feeding. This summary was generated with AI assistance to help patients understand the study in plain language.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DIETARY_SUPPLEMENTThickened feeds
Thickened feeds directed by medical team
DIETARY_SUPPLEMENTNon-thickened feeds
Non-thickened feeds directed by medical team
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04477460
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