Effects of thickened feeds on infants with unexplained life-threatening events
Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
This study is trying to see if giving thicker feeds to infants who have had scary unexplained events helps improve their health and reduces the need for medical care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 0 Months to 12 Months |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04477460 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how thickened feeds impact clinical outcomes and healthcare utilization in infants who have experienced brief resolved unexplained events (BRUE). BRUE episodes can be alarming and are often associated with oropharyngeal dysphagia, which may contribute to ongoing symptoms. The study will follow a cohort of infants receiving thickened feeds compared to those on non-thickened feeds over the course of one year to assess the potential benefits of this intervention. The goal is to better understand the relationship between feeding modifications and the management of BRUE.
Who should consider this trial
Good fit: Ideal candidates for this study are infants under one year of age who have been admitted to Boston Children's Hospital after their first BRUE episode.
Not a fit: Patients with pre-existing medical conditions that exclude a BRUE diagnosis or those already receiving thickened liquids for other reasons may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for infants experiencing BRUE, potentially reducing morbidity associated with these events.
How similar studies have performed: While there is limited research specifically on thickened feeds for BRUE, the study addresses a significant gap in understanding swallowing dysfunction in this population, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Less than 1 year of age * Admitted to Boston Children's Hospital after experiencing first lifetime brief resolved unexplained event. Exclusion Criteria: * 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
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Daniel R Duncan, MD, MPH — Boston Children's Hospital
- Study coordinator: Daniel R Duncan, MD, MPH
- Email: daniel.duncan@childrens.harvard.edu
- Phone: 6173550897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.