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
0 Years
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: