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RecruitingNCT04477460BRUEUpdated Mar 18, 2026

Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event

An observational study in Brief Resolved Unexplained Event, Apparent Life Threatening Event and Oropharyngeal Dysphagia, sponsored by Boston Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 0 Months to 12 Months. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Boston Children's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
0 Months to 12 Months
Sex
All
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Study summary

This observational study will examine the effects of thickened feeds on clinical outcomes and healthcare utilization in infants with brief resolved unexplained event (BRUE).

Read the detailed description

Brief resolved unexplained events (BRUE) are frightening episodes characterized by the appearance of life-threatening choking, pallor, cyanosis, and limpness in infants. These common events are resource-intensive and current management approaches inadequately address persistent symptoms. Infants with BRUE commonly have oropharyngeal dysphagia with aspiration, which is a modifiable risk factor for persistent symptoms, but there are no studies determining the mechanism behind this swallowing dysfunction and if swallowing interventions reduce morbidity. This is a prospective, longitudinal cohort study of infants who experienced brief resolved unexplained event receiving thickened feedings compared to those not receiving thickened feedings over 1 year.

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Conditions studied

  • Brief Resolved Unexplained Event
  • Apparent Life Threatening Event
  • Oropharyngeal Dysphagia

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Who can participate

Ages eligible
0 Months to 12 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Less than 1 year of age
  • Admitted to Boston Children's Hospital after experiencing first lifetime brief resolved unexplained event.

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Infants with BRUE receiving thickened feeds

    Dietary Supplement: Thickened feeds

  • Infants with BRUE not receiving thickened feeds

    Dietary Supplement: Non-thickened feeds

Interventions

  • Dietary supplementThickened feeds

    Thickened feeds directed by medical team

  • Dietary supplementNon-thickened feeds

    Non-thickened feeds directed by medical team

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. Frequency of persistent symptoms and hospitalization risk over the full 12-month follow-up period

    Symptoms and hospitalization risk over the full 12-month follow-up period, optimal period of time needed for thickening, parent-reported anxiety levels, cost of care at Boston Children's Hospital, potential adverse effects of thickening, and urine arsenic levels, all compared between subjects receiving and not receiving thickened feeds.

    Time frame: 12 months

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 31103259 ↗
  • 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. PubMed 27741062 ↗
  • 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. PubMed 36336644 ↗
  • 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. PubMed 38815745 ↗
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Registry details

Key details

Study ID
NCT04477460
Lead sponsor
Boston Children's Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Daniel Duncan (Assistant Professor of Pediatrics, Boston Children's Hospital) — Principal investigator
First posted
Jul 20, 2020
Start date
Apr 1, 2021
Primary completion
Aug 31, 2026 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Mar 18, 2026

Study contacts

Daniel R Duncan, MD, MPH
Contact
daniel.duncan@childrens.harvard.edu
6173550897
Daniel R Duncan, MD, MPH
principal investigator · Boston Children's Hospital
Rachel Rosen, MD, MPH
study director · Boston Children's Hospital
Sudarshan Jadcherla, MD
study director · Nationwide Children's Hospital
Taher Omari, PhD
study director · Flinders University
Samuel Nurko, MD, MPH
study director · Boston Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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