NCT03130543

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 0 Years – 1 Year
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Apparent Life Threatening Event
• Gastroesophageal Reflux
• Aspiration

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Rice cereal	Standard formula thickened with rice cereal
DIETARY_SUPPLEMENT	Enfamil AR	Enfamil AR formula

Timeline

• Start date: 2017-04-24
• Primary completion: 2021-04-02
• Completion: 2021-04-02
• First posted: 2017-04-26
• Last updated: 2021-04-06

Locations

1 site across 1 country: United States