Gastric Emptying in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Gastric Antral Volumes in Newborns
研究概览
简要总结
Ultrasound imaging will be used to evaluate time for gastric emptying in healthy, fasting newborns, and infants following feeding of clear liquids and/or milk (including breast or formula).
详细描述
The study involves serial ultrasounds over several visits. Healthy newborns in the Newborn Nursery will be recruited to conduct this study. The study will include a total of 50 healthy newborns who will be given formula feeding of known volume, and then serial ultrasound imaging of gastric antral volume will be performed until gastric emptying.
The study originally was designed to perform follow up of these newborns at two later time intervals (between ages 4-6 months, and 9-12 months). The purpose of follow-up is to evaluate whether there are age-related changes in gastric emptying. Due to the pause/suspension of research activity during the pandemic, these follow up studies of the original newborn cohort could not be completed. The protocol is thus revised as follows:
The study will recruit 50 4-6 months old and 50 9-12months old infants and perform gastric emptying serial ultrasound to evaluate if there are age-related changes in gastric emptying.
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
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Gastric Antral Volumes in Newborns
时间窗: Up to 6 hours
To determine gastric emptying time in newborns, serial gastric antral volumes will be measured before and after formula feeding until return to baseline measurements at 10-15 minute intervals.
次要结局
- Gastric Antral Volumes in Infants(Up to 6 hours)
研究者
Lena S. Sun
Emanuel M. Papper Professor of Anesthesiology and Professor of Pediatrics
Columbia University