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

Stopped early · Not applicable

Conditions studied: Apparent Life Threatening Event, Gastroesophageal Reflux, Aspiration

In brief

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.

Key facts

Study ID

NCT03130543

Run by

Boston Children's Hospital

People needed

3

Starts

2017-04-24

Expected to finish

2021-04-02

Last updated by the study team

2021-04-06

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients less than 12 months of age who have been admitted to the hospital after brief resolved unexplained event

You may not qualify if…

• 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

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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