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)

Boston Children's Hospital

Boston, Massachusetts, United States

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NCT04477460


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