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

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

Detailed Description
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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.

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

Conditions
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Brief Resolved Unexplained Event, Apparent Life Threatening Event, Oropharyngeal Dysphagia

Intervention / Treatment
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* Dietary Supplement: Thickened feeds
* Dietary Supplement: Non-thickened feeds


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants with BRUE receiving thickened feeds<br> | Dietary Supplement: Thickened feeds<br>* Thickened feeds directed by medical team<br>|
| Infants with BRUE not receiving thickened feeds<br> | Dietary Supplement: Non-thickened feeds<br>* Non-thickened feeds directed by medical team<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |