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

Boston Children's Hospital3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Apparent Life Threatening Event Gastroesophageal Reflux

Eligibility

Sex: ALLMin age: 0 YearsMax age: 1 Year

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Choking episodes

Frequency of choking episodes

Time frame: 2 weeks

Secondary Outcomes

Choking episodes

Frequency of choking episodes

Time frame: 12 months

Repeat hospital admission

Number of hospitalizations after randomization

Time frame: 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

Time frame: 2 months

Urine concentration

Change in urine concentration after randomization