250 Participants Needed

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

(BRUE Trial)

DR
Overseen ByDaniel R Duncan, MD, MPH
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Boston Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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

Research Team

DR

Daniel R Duncan, MD, MPH

Principal Investigator

Boston Children's Hospital

SJ

Sudarshan Jadcherla, MD

Principal Investigator

Nationwide Children's Hospital

RR

Rachel Rosen, MD, MPH

Principal Investigator

Boston Children's Hospital

TO

Taher Omari, PhD

Principal Investigator

Flinders University

SN

Samuel Nurko, MD, MPH

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

Inclusion Criteria

Less than 1 year of age
Admitted to Boston Children's Hospital after experiencing first lifetime brief resolved unexplained event.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Infants with BRUE are observed for clinical outcomes with or without thickened feeds

12 months

Follow-up

Participants are monitored for safety and effectiveness after the observation period

6 months

Treatment Details

Interventions

  • Non-thickened feeds
  • Thickened feeds
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Infants with BRUE receiving thickened feedsExperimental Treatment1 Intervention
Group II: Infants with BRUE not receiving thickened feedsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+
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