跳至主要内容
临床试验/NCT03130543
NCT03130543终止不适用

A Randomized Trial of Thickened Feeds to Treat Gastroesophageal Reflux in Children Admitted to Boston Children's Hospital After Brief Resolved Unexplained Event

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2017年4月24日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rachel Rosen

Associate Professor of Pediatrics

Boston Children's Hospital

研究点 (2)

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