A Trial of Thickened Feeds to Treat Gastroesophageal Reflux in Children Admitted After Choking Spell

Study Overview
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Brief Summary
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Infants often present to the hospital with episodes of coughing, choking, gagging, change in muscle tone, and/or change in skin color, known as brief resolved unexplained event. Many studies have tried to address why infants have these symptoms and if there is a way to prevent them from happening again. Currently, there is no clear agreement on the most common cause of these symptoms or how to prevent them. Some studies have suggested that gastroesophageal reflux can cause these symptoms. The investigators are conducting a study of infants who are admitted to Boston Children's Hospital with episodes of coughing, choking, gagging, change in muscle tone, and/or change in skin color, symptoms that could be reflux. The investigators want to determine if these symptoms can be prevented by changing the way infants are fed, either by giving them a formula to treat reflux or by thickening their feeds to treat reflux. The goal of the study is to determine if different types of feeding interventions prevent infants from coming back to the hospital.

Official Title
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A Randomized Trial of Thickened Feeds to Treat Gastroesophageal Reflux in Children Admitted to Boston Children's Hospital After Brief Resolved Unexplained Event

Conditions
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Apparent Life Threatening Event, Gastroesophageal Reflux, Aspiration

Intervention / Treatment
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* Dietary Supplement: Rice cereal
* Dietary Supplement: Enfamil AR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients less than 12 months of age who have been admitted to the hospital after brief resolved unexplained event Exclusion Criteria: Patients with any pre-existing significant medical diagnosis (congenital heart disease, known neurologic impairment with or without seizure disorder, other congenital anomalies) Patients with any prior hospitalization for BRUE Patients with food allergies such that they cannot be on a milk or rice based diet Any patient exclusively breastfed because change to a formula or adding thickening is not possible unless patients choose to pump breast milk and stop all nursing

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 1 Year

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Formula<br>This is the group of subjects randomized to receive their standard formula | |
| Experimental: Standard Formula with Rice Cereal<br>This is the group of subjects randomized to receive their standard formula with rice cereal added | Dietary Supplement: Rice cereal<br>* Standard formula thickened with rice cereal<br>|
| Experimental: Enfamil AR<br>This is the group of subjects randomized to receive Enfamil AR | Dietary Supplement: Enfamil AR<br>* Enfamil AR formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choking episodes | Frequency of choking episodes | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choking episodes | Frequency of choking episodes | 12 months | 
| Repeat hospital admission | Number of hospitalizations after randomization | 12 months | 
| Microbiome changes | Prior studies have suggested that infant thickeners can be associated with necrotizing enterocolitis in infants; the aim of this secondary outcome measure will be to evaluate for changes in microbiome (particularly toward a more pathogenic microbiome) after randomization | 2 months | 
| Urine concentration | Change in urine concentration after randomization | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brief resolved unexplained event