Apparent Life Threatening Event, Aspiration, Gastroesophageal Reflux
Conditions
Keywords
Brief resolved unexplained event
Brief 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.
Interventions
DIETARY_SUPPLEMENTRice cereal
Standard formula thickened with rice cereal
DIETARY_SUPPLEMENTEnfamil AR
Enfamil AR formula
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 1 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Choking episodes | 2 weeks | Frequency of choking episodes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Choking episodes | 12 months | Frequency of choking episodes |
| Repeat hospital admission | 12 months | Number of hospitalizations after randomization |
| Microbiome changes | 2 months | 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 |
| Urine concentration | 2 months | Change in urine concentration after randomization |
Countries
United States
Outcome results
None listed