A Randomized Trial of Thickened Feeds to Treat Gastroesophageal Reflux in Children Admitted to Boston Children's Hospital After Brief Resolved Unexplained Event
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Choking episodes
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 1 Year(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients less than 12 months of age who have been admitted to the hospital after brief resolved unexplained event
排除标准
- •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
结局指标
主要结局
Choking episodes
时间窗: 2 weeks
Frequency of choking episodes
次要结局
- Choking episodes(12 months)
- Repeat hospital admission(12 months)
- Microbiome changes(2 months)
- Urine concentration(2 months)
研究者
Rachel Rosen
Associate Professor of Pediatrics
Boston Children's Hospital
