Brief Resolved Unexplained EventBRUENCT04477460
Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
An observational study of Brief Resolved Unexplained Event and Apparent Life Threatening Event, run by Boston Children's Hospital at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 0 to 12 months
- Conditions the study is for
- Brief Resolved Unexplained Event, Apparent Life Threatening Event, Oropharyngeal Dysphagia
- What is being tested?
- Thickened feeds and Non-thickened feeds
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 31 Aug 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 12 months
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- Less than 1 year of age
- Admitted to Boston Children's Hospital after experiencing first lifetime brief resolved unexplained event.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Daniel R Duncan, MD, MPH, 6173550897, daniel.duncan@childrens.harvard.edu
About this study
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.
- Conditions
- Brief Resolved Unexplained Event, Apparent Life Threatening Event, Oropharyngeal Dysphagia
- Being tested
- Thickened feeds, Non-thickened feeds
- Medical subject headings
- Brief, Resolved, Unexplained Event, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thickened feedsDietary supplement
Thickened feeds directed by medical team
Non-thickened feedsDietary supplement
Non-thickened feeds directed by medical team
| Study group | Role | What they receive |
|---|---|---|
| Infants with BRUE receiving thickened feeds | Not described Receives: Dietary Supplement: Thickened feeds | |
| Infants with BRUE not receiving thickened feeds | Not described Receives: Dietary Supplement: Non-thickened feeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Apr 2021
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Brief Resolved Unexplained EventStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Duncan, Boston Children's Hospital
- Investigators
- Daniel R Duncan, MD, MPH, Principal investigator, Boston Children's HospitalRachel Rosen, MD, MPH, Study director, Boston Children's HospitalSudarshan Jadcherla, MD, Study director, Nationwide Children's HospitalTaher Omari, PhD, Study director, Flinders UniversitySamuel Nurko, MD, MPH, Study director, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477460
- Sponsor's protocol ID
- IRB-P00038785
- Other IDs
- K23DK127251
- Acronym
- BRUE
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2020
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 31103259Duncan 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 27741062Duncan 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 36336644Duncan 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.
PubMed 39871744Duncan 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