NCT04477460|Recruiting
Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
BRUE
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BRUE
Sponsor study identifier
Secondary identifiers
NIH
observational
250
1 country
1
Study Start
April 1, 2021
Actual (reported)Primary Completion
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This observational study will examine the effects of thickened feeds on clinical outcomes and healthcare utilization in infants with brief resolved unexplained event (BRUE).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 15, 2020
Actual (reported)July 20, 2020
Actual (reported)April 1, 2021
Actual (reported)August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Frequency of persistent symptoms and repeat hospitalizations over 6-month follow-up period
Frequency of persistent symptoms and repeat hospitalizations over the 6 months after enrollment, with a comparison between those receiving and not receiving thickened feeds.
6 months
Frequency of persistent symptoms and hospitalization risk over the full 12-month follow-up period
12 months
Thickened feeds directed by medical team
Non-thickened feeds directed by medical team
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Participants will be eligible for the study if they are less than 1 year of age and admitted to Boston Children's Hospital after experiencing first lifetime BRUE
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
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.
Urine samples
Daniel R Duncan, MD, MPH
Boston Children's Hospital
Rachel Rosen, MD, MPH
Boston Children's Hospital
Sudarshan Jadcherla, MD
Nationwide Children's Hospital
Taher Omari, PhD
Flinders University
First Submitted
July 15, 2020
First Posted
July 20, 2020
Study Start
April 1, 2021
Actual (reported)Primary Completion
August 31, 2027
EstimatedPulmonary Health in Children With Down Syndrome
Contact the study team to confirm eligibility.
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.
Duncan DR, Golden C, Larson K, Growdon AS, Liu E. A prospective study of diagnostic testing and hospital charges after brief resolved unexplained event. J Pediatr Gastroenterol Nutr. 2025 Apr;80(4):623-632. doi: 10.1002/jpn3.12465. Epub 2025 Jan 28.
Duncan DR, Golden C, Growdon AS, Larson K, Rosen RL. Brief Resolved Unexplained Events Symptoms Frequently Result in Inappropriate Gastrointestinal Diagnoses and Treatment. J Pediatr. 2024 Sep;272:114128. doi: 10.1016/j.jpeds.2024.114128. Epub 2024 May 28.
Samuel Nurko, MD, MPH
Boston Children's Hospital
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 22, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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