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

Oropharyngeal Dysphagia Clinical Trial

— BRUE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04477460
• Other study ID #: ObservationalBRUE
• Secondary ID: K23DK127251
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: August 31, 2025

Study information

• Verified date: April 2024
• Source: Boston Children's Hospital
• Contact: Daniel R Duncan, MD, MPH
• Phone: 6173550897
• Email: daniel.duncan[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Months to 12 Months

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Thickened feeds
Thickened feeds directed by medical team
• Non-thickened feeds
Non-thickened feeds directed by medical team

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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