Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
NCT ID: NCT04477460
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2021-04-01
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Infants with BRUE receiving thickened feeds
Thickened feeds
Thickened feeds directed by medical team
Infants with BRUE not receiving thickened feeds
Non-thickened feeds
Non-thickened feeds directed by medical team
Interventions
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Thickened feeds
Thickened feeds directed by medical team
Non-thickened feeds
Non-thickened feeds directed by medical team
Eligibility Criteria
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Inclusion Criteria
* Admitted to Boston Children's Hospital after experiencing first lifetime brief resolved unexplained event.
Exclusion Criteria
* Already receiving thickened liquids for treatment of another condition
0 Months
12 Months
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Boston Children's Hospital
OTHER
Responsible Party
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Daniel Duncan
Assistant Professor of Pediatrics
Principal Investigators
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Sudarshan Jadcherla, MD
Role: STUDY_DIRECTOR
Nationwide Children's Hospital
Taher Omari, PhD
Role: STUDY_DIRECTOR
Flinders University
Samuel Nurko, MD, MPH
Role: STUDY_DIRECTOR
Boston Children's Hospital
Daniel R Duncan, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Rachel Rosen, MD, MPH
Role: STUDY_DIRECTOR
Boston Children's Hospital
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Duncan DR, Growdon AS, Liu E, Larson K, Gonzalez M, Norris K, Rosen RL. The Impact of the American Academy of Pediatrics Brief Resolved Unexplained Event Guidelines on Gastrointestinal Testing and Prescribing Practices. J Pediatr. 2019 Aug;211:112-119.e4. doi: 10.1016/j.jpeds.2019.04.007. Epub 2019 May 15.
Duncan DR, Amirault J, Mitchell PD, Larson K, Rosen RL. Oropharyngeal Dysphagia Is Strongly Correlated With Apparent Life-Threatening Events. J Pediatr Gastroenterol Nutr. 2017 Aug;65(2):168-172. doi: 10.1097/MPG.0000000000001439.
Duncan DR, Liu E, Growdon AS, Larson K, Rosen RL. A Prospective Study of Brief Resolved Unexplained Events: Risk Factors for Persistent Symptoms. Hosp Pediatr. 2022 Dec 1;12(12):1030-1043. doi: 10.1542/hpeds.2022-006550.
Other Identifiers
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IRB-P00038785
Identifier Type: -
Identifier Source: org_study_id
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