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NCT Number: NCT04477460

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

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

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Key information

Conditions

Brief Resolved Unexplained Event Apparent Life Threatening Event Brief, Resolved, Unexplained Event Cyanosis Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Oropharyngeal Dysphagia Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

0 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Daniel R Duncan, MD, MPH

CONTACT

[email protected]

6173550897

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thickened feeds

Dietary Supplement

Thickened feeds directed by medical team

Non-thickened feeds

Dietary Supplement

Non-thickened feeds directed by medical team

Primary outcomes

  1. Frequency of persistent symptoms and repeat hospitalizations over 6-month follow-up period

    Time frame: 6 months

    Frequency of persistent symptoms and repeat hospitalizations over the 6 months after enrollment, with a comparison between those receiving and not receiving thickened feeds.

Secondary outcomes

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

    Time frame: 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel R Duncan, MD, MPH

CONTACT

[email protected]

6173550897

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: BRUE

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2020
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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