Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Frequency of persistent symptoms and repeat hospitalizations over 6-month follow-up period
研究概览
简要总结
This observational study will examine the effects of thickened feeds on clinical outcomes and healthcare utilization in infants with brief resolved unexplained event (BRUE).
详细描述
Brief resolved unexplained events (BRUE) are frightening episodes characterized by the appearance of life-threatening choking, pallor, cyanosis, and limpness in infants. These common events are resource-intensive and current management approaches inadequately address persistent symptoms. Infants with BRUE commonly have oropharyngeal dysphagia with aspiration, which is a modifiable risk factor for persistent symptoms, but there are no studies determining the mechanism behind this swallowing dysfunction and if swallowing interventions reduce morbidity. This is a prospective, longitudinal cohort study of infants who experienced brief resolved unexplained event receiving thickened feedings compared to those not receiving thickened feedings over 1 year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than 1 year of age
- •Admitted to Boston Children's Hospital after experiencing first lifetime brief resolved unexplained event.
排除标准
- •Any pre-existing medical diagnoses that exclude brief resolved unexplained event diagnosis including seizure disorders and cyanotic congenital heart disease
- •Already receiving thickened liquids for treatment of another condition
研究组 & 干预措施
Infants with BRUE receiving thickened feeds
干预措施: Thickened feeds (Dietary Supplement)
Infants with BRUE not receiving thickened feeds
干预措施: Non-thickened feeds (Dietary Supplement)
结局指标
主要结局
Frequency of persistent symptoms and repeat hospitalizations over 6-month follow-up period
时间窗: 6 months
Frequency of persistent symptoms and repeat hospitalizations over the 6 months after enrollment, with a comparison between those receiving and not receiving thickened feeds.
次要结局
- Frequency of persistent symptoms and hospitalization risk over the full 12-month follow-up period(12 months)
研究者
Daniel Duncan
Assistant Professor of Pediatrics
Boston Children's Hospital