Current Environment:

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

Recruitment Status

Terminated

Eligibility Criteria

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

Intervention

Intervention Type

Intervention Name

Dietary Supplement

Rice cereal

Dietary Supplement

Enfamil AR

Phase

Not Applicable

Gender

All

Min Age

N/A

Max Age

1 Year

Download Date

April 6, 2021

Principal Investigator

Rachel Rosen

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: