Health TrialsbyHealthPanel

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

ConditionsBrief Resolved Unexplained EventApparent Life Threatening EventOropharyngeal Dysphagia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-12
SponsorBoston Children's Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Less than 1 year of age

Admitted to Boston Children's Hospital after experiencing first lifetime brief resolved unexplained event.

Disqualifiers

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

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Thickened feeds

    Dietary supplement

    Thickened feeds directed by medical team

  • Non-thickened feeds

    Dietary supplement

    Non-thickened feeds directed by medical team

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Infants with BRUE receiving thickened feeds1 intervention
Group B: Infants with BRUE not receiving thickened feeds1 intervention

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Children's Hospital

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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