A Trial of Thickened Feeds to Treat Gastroesophageal Reflux in Children Admitted After Choking Spell
| Status: | Recruiting |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any - 1 |
| Updated: | 5/30/2018 |
| Start Date: | April 24, 2017 |
| End Date: | March 6, 2022 |
| Contact: | Daniel R Duncan, MD |
| Email: | daniel.duncan@childrens.harvard.edu |
| Phone: | 617-355-6058 |
A Randomized Trial of Thickened Feeds to Treat Gastroesophageal Reflux in Children Admitted to Boston Children's Hospital After Brief Resolved Unexplained Event
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.
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.
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
We found this trial at
1
site
300 Longwood Ave
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 355-6000
Phone: 617-355-6058
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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