The Impact of the American Academy of Pediatrics Brief Resolved Unexplained Event Guidelines on Gastrointestinal Testing and Prescribing Practices.
Daniel R Duncan, Amanda S Growdon, Enju Liu...
https://pubmed.ncbi.nlm.nih.gov/31103259Actively Recruiting
Age: 0Months - 12Months
All Genders
ID04477460
Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
Led by Boston Children's Hospital · Updated on 2026-03-18
250
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Boston Children's Hospital
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study investigates infants who have experienced brief resolved unexplained events (BRUE), which are sudden, alarming episodes involving choking, color changes, and limpness. Researchers aim to understand how thickened feedings affect clinical outcomes and healthcare use in these infants, particularly focusing on swallowing difficulties that may contribute to ongoing symptoms. Participants are divided into two groups: those receiving thickened feeds and those receiving non-thickened feeds, both managed by their medical team. This observational study follows infants for one year to compare outcomes between these two feeding approaches. Throughout the study, researchers track the frequency of persistent symptoms and repeat hospitalizations over six months as the primary measure, with additional monitoring extending to 12 months. Data collection includes clinical assessments to understand swallowing function and symptom progression, providing insight into how feeding interventions may influence health over time.
CONDITIONS
Brief Title
Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
Who Can Participate
Age: 0Months - 12Months
All Genders
Eligibility Criteria
You may qualify if you...
- Less than 1 year of age
- Admitted to Boston Children's Hospital after experiencing first lifetime brief resolved unexplained event
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - 12 months
Participants who receive either thickened or non-thickened feeds are observed for clinical outcomes related to brief resolved unexplained events over time.
Periodic visits during the 12-month follow-up period
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
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Research Team
D
Daniel R Duncan, MD, MPH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Oropharyngeal Dysphagia Is Strongly Correlated With Apparent Life-Threatening Events.
Daniel R Duncan, Janine Amirault, Paul D Mitchell...
https://pubmed.ncbi.nlm.nih.gov/27741062A Prospective Study of Brief Resolved Unexplained Events: Risk Factors for Persistent Symptoms.
Daniel R Duncan, Enju Liu, Amanda S Growdon...
https://pubmed.ncbi.nlm.nih.gov/36336644Brief Resolved Unexplained Events Symptoms Frequently Result in Inappropriate Gastrointestinal Diagnoses and Treatment.
Daniel R Duncan, Clare Golden, Amanda S Growdon...
https://pubmed.ncbi.nlm.nih.gov/38815745