What this study is
This observational study will examine the effects of thickened feeds on clinical outcomes and healthcare utilization in infants with brief resolved unexplained event (BRUE).
What's being tested
- Thickened feeds
Intervention · DIETARY SUPPLEMENT
Thickened feeds directed by medical team
- Non-thickened feeds
Intervention · DIETARY SUPPLEMENT
Non-thickened feeds directed by medical team
Study details
- Sponsor
- Boston Children's Hospital
- Conditions
- Brief Resolved Unexplained Event · Apparent Life Threatening Event · Oropharyngeal Dysphagia
- Enrolling
- 250 people
- Starts
- 2021-04-01
- Est. completion
- 2027-08-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 0 Months – 12 MonthsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Less than 1 year of age
- Admitted to Boston Children's Hospital after experiencing first lifetime brief resolved unexplained event.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openBoston Children's Hospital
Boston, Massachusetts, United States
- Daniel R Duncan, MD, MPH · Contact6173550897daniel.duncan@childrens.harvard.edu
Recruiting
Study team
Sponsor
Boston Children's Hospital
Study ID IRB-P00038785
Principal investigator
Daniel R Duncan, MD, MPH
Boston Children's Hospital
Study director
Rachel Rosen, MD, MPH
Boston Children's Hospital
Study director
Sudarshan Jadcherla, MD
Nationwide Children's Hospital
Study director
Taher Omari, PhD
Flinders University
Study director
Samuel Nurko, MD, MPH
Boston Children's Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.