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

NCT04477460 | Recruiting

• 2 other identifiers: IRB-P00038785K23DK127251
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Outcome Measures

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.

  6 months

Secondary Outcomes (1)

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

  12 months

Study Arms (2)

Infants with BRUE receiving thickened feeds

Dietary Supplement: Thickened feeds

Infants with BRUE not receiving thickened feeds

Dietary Supplement: Non-thickened feeds

Interventions

Thickened feeds DIETARY_SUPPLEMENT

Thickened feeds directed by medical team

Infants with BRUE receiving thickened feeds

Non-thickened feeds DIETARY_SUPPLEMENT

Non-thickened feeds directed by medical team

Infants with BRUE not receiving thickened feeds

Eligibility Criteria

• Age: 0 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples

MeSH Terms

Conditions

Brief, Resolved, Unexplained Event; Deglutition Disorders

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Cyanosis; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Daniel R Duncan, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Central Study Contacts

Daniel R Duncan, MD, MPH

CONTACT

6173550897; daniel.duncan@childrens.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 20, 2020
• Study Start: April 1, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (1)