Recruiting

Thickened Feeds

Sponsor:

Boston Children's Hospital

Code:

NCT04477460

Conditions

Brief Resolved Unexplained Event

Apparent Life Threatening Event

Oropharyngeal Dysphagia

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Thickened feeds

Non-thickened feeds

Study Details

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

Study ID

NCT04477460

Start date

Apr 1, 2021

Status verified date

Mar, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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 Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Infants with BRUE receiving thickened feeds

Infants with BRUE not receiving thickened feeds

Interventions

Thickened feeds

Thickened feeds directed by medical team

Non-thickened feeds

Non-thickened feeds directed by medical team

Primary outcome measure

  • Frequency of persistent symptoms and repeat hospitalizations over 6-month follow-up period [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Daniel R Duncan, MD, MPH

6173550897daniel.duncan@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Daniel R Duncan, MD, MPH

6173550897daniel.duncan@childrens.harvard.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-03-18.