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Recruiting NCT04477460

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

— Observational Brief Resolved Unexplained Event Apparent Life Threatening Event Oropharyngeal Dysphagia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thickened feeds, Non-thickened feeds.
Who it may be relevant to
Registry conditions: Brief Resolved Unexplained Event, Apparent Life Threatening Event, Oropharyngeal Dysphagia. Basic parameters: 0 months — 12 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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.

Interventions

  • Dietary supplement Thickened feeds
    Thickened feeds directed by medical team
  • Dietary supplement Non-thickened feeds
    Non-thickened feeds directed by medical team

Primary outcome measures

  • Frequency of persistent symptoms and repeat hospitalizations over 6-month follow-up period [Time frame: 6 months]
Secondary outcome measures (1)
  • Frequency of persistent symptoms and hospitalization risk over the full 12-month follow-up period [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Boston Children's Hospital — Boston

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. PMID 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. PMID 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. PMID 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. PMID 38815745

Identifiers

NCT: NCT04477460 · IRB-P00038785 · K23DK127251

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗