Clinical trial NCT03130543: A Trial of Thickened Feeds to Treat Gastroesophageal Reflux in Children Admitted After Choking Spell
Official title: A Randomized Trial of Thickened Feeds to Treat Gastroesophageal Reflux in Children Admitted to Boston Children's Hospital After Brief Resolved Unexplained Event
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Apparent Life Threatening Event
Gastroesophageal Reflux
Aspiration
Keywords: Brief resolved unexplained event
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 3
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Choking episodes
timeFrame: 2 weeks
Secondary outcomes:
measure: Choking episodes
timeFrame: 12 months
measure: Repeat hospital admission
timeFrame: 12 months
measure: Microbiome changes
timeFrame: 2 months
measure: Urine concentration
timeFrame: 2 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Rachel L Rosen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duncan DR, Amirault J, Mitchell PD, Larson K, Rosen RL. Oropharyngeal Dysphagia Is Strongly Correlated With Apparent Life-Threatening Events. J Pediatr Gastroenterol Nutr. 2017 Aug;65(2):168-172. doi: 10.1097/MPG.0000000000001439.