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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT04477460
Status
Recruiting
Apply to this trial

Conditions

  • Apparent Life Threatening Event
  • Brief Resolved Unexplained Event
  • Oropharyngeal Dysphagia

Eligibility Criteria

Sex
ALL
Age
0 Months - 12 Months
Healthy Volunteers
Not accepted

Interventions

  • Thickened feeds — DIETARY_SUPPLEMENT
    Thickened feeds directed by medical team
  • Non-thickened feeds — DIETARY_SUPPLEMENT
    Non-thickened feeds directed by medical team

Study Details

This observational study will examine the effects of thickened feeds on clinical outcomes and healthcare utilization in infants with brief resolved unexplained event (BRUE).

Key Dates

Start date
Apr 1, 2021
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: Infants with BRUE receiving thickened feeds
  • Arm: Infants with BRUE not receiving thickened feeds

Primary Outcome Measure

Frequency of persistent symptoms and repeat hospitalizations over 6-month follow-up period [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Daniel R Duncan, MD, MPH
[email protected]
6173550897

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By research site
Boston Children's Hospital· Boston, MA

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