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

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

Study Overview

• Status: Recruiting
• Conditions: Oropharyngeal Dysphagia; Brief Resolved Unexplained Event; Apparent Life Threatening Event
• Intervention / Treatment: Dietary supplement: Thickened feeds; Dietary supplement: Non-thickened feeds

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Daniel R Duncan, MD, MPH; Phone Number: 6173550897; Email: daniel.duncan@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Daniel R Duncan, MD, MPH; Phone Number: 617-355-0897; Email: daniel.duncan@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 year (Child)
• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infants with BRUE receiving thickened feeds	Dietary supplement: Thickened feeds; Thickened feeds directed by medical team
Infants with BRUE not receiving thickened feeds	Dietary supplement: Non-thickened feeds; Non-thickened feeds directed by medical team

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Daniel R Duncan, MD, MPH, Boston Children's Hospital; Study Director: Rachel Rosen, MD, MPH, Boston Children's Hospital; Study Director: Sudarshan Jadcherla, MD, Nationwide Children's Hospital; Study Director: Taher Omari, PhD, Flinders University; Study Director: Samuel Nurko, MD, MPH, Boston Children's Hospital

Publications and helpful links

General Publications

• 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, 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, 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Respiration Disorders; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Esophageal Diseases; Respiratory Insufficiency; Cyanosis; Deglutition Disorders; Brief, Resolved, Unexplained Event
• Other Study ID Numbers: ObservationalBRUE; K23DK127251 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No