Thickened Feeds for Brief Resolved Unexplained Events
(BRUE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how thickened feeds (liquids made thicker) affect the health and medical visits of infants who have experienced a brief resolved unexplained event (BRUE). A BRUE is a sudden, alarming episode where a baby stops breathing or becomes very limp but then quickly recovers. Researchers will compare two groups: one receiving thickened feeds and another receiving non-thickened feeds. Infants who might be suitable candidates have had their first BRUE and are receiving treatment at Boston Children's Hospital. As an unphased trial, this study provides a unique opportunity for parents to contribute to research that could enhance care for infants experiencing BRUE.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It focuses on infants and their feeding, so it's best to consult with the trial coordinators for specific guidance.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that infants usually tolerate thickened feeds well. Studies have not identified any major negative effects from these feeds. They help infants swallow better and reduce reflux. However, each infant may react differently. Some might experience mild side effects, such as changes in stool, but these are generally not serious. Overall, evidence suggests that thickened feeds are a safe way to manage feeding issues in infants with brief resolved unexplained events (BRUE).12345
Why are researchers excited about this trial?
Researchers are excited about the trial of thickened feeds for infants with Brief Resolved Unexplained Events (BRUE) because it offers a potentially simple and effective approach to managing these episodes. Unlike traditional interventions that may involve extensive monitoring or medication, thickened feeds could provide an immediate and non-invasive option for parents and healthcare providers. This method aims to reduce the risk of future unexplained events by potentially improving feeding safety and decreasing the likelihood of aspiration. This approach represents a shift towards a more manageable and parental-friendly intervention in addressing BRUE, which could lead to improved clinical outcomes with minimal disruption to the infant's care routine.
What evidence suggests that this trial's treatments could be effective for infants with BRUE?
Research has shown that thickened feeds can help infants who have experienced a brief resolved unexplained event (BRUE). In this trial, some infants will receive thickened feeds, which studies have found reduce spit-up, a common concern in these situations. Thickened feeds commonly prevent food or liquid from entering the airway and effectively address feeding problems. While more research is needed specifically for BRUE, current evidence suggests that thickened feeds can be beneficial.12346
Who Is on the Research Team?
Daniel R Duncan, MD, MPH
Principal Investigator
Boston Children's Hospital
Sudarshan Jadcherla, MD
Principal Investigator
Nationwide Children's Hospital
Rachel Rosen, MD, MPH
Principal Investigator
Boston Children's Hospital
Taher Omari, PhD
Principal Investigator
Flinders University
Samuel Nurko, MD, MPH
Principal Investigator
Boston Children's Hospital
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Observation
Infants with BRUE are observed for clinical outcomes with or without thickened feeds
Follow-up
Participants are monitored for safety and effectiveness after the observation period
What Are the Treatments Tested in This Trial?
Interventions
- Non-thickened feeds
- Thickened feeds
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Children's Hospital
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Citations
Study Details | NCT04477460 | Effect of Thickened Feeds ...
This observational study will examine the effects of thickened feeds on clinical outcomes and healthcare utilization in infants with brief resolved unexplained ...
A Prospective Study of Brief Resolved Unexplained Events
Fortunately, thickening of feeds, a mainstay of aspiration therapy (and an effective therapy for regurgitation), has been shown to decrease ...
3.
ctv.veeva.com
ctv.veeva.com/study/effect-of-thickened-feeds-on-clinical-outcomes-in-children-with-brief-resolved-unexplained-eventEffect of Thickened Feeds on Clinical Outcomes in Children ...
This is a prospective, longitudinal cohort study of infants who experienced brief resolved unexplained event receiving thickened feedings ...
NCT04477460
This observational study will examine the effects of thickened feeds on clinical outcomes and healthcare utilization in infants with brief resolved unexplained ...
5.
researchgate.net
researchgate.net/publication/352729131_Risk_Factors_and_Outcomes_After_a_Brief_Resolved_Unexplained_Event_A_Multicenter_StudyRisk Factors and Outcomes After a Brief Resolved ...
Results: Of 2036 patients presenting with a BRUE, 87% had at least 1 AAP higher-risk factor. Revisits occurred in 6.9% of ED and 10.7% of ...
Brief Resolved Unexplained Events Symptoms Frequently ...
We performed a prospective cohort study of infants with BRUE to review presenting symptoms and their potential impact on testing and treatment.
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