Physiopathology of Dumping Syndrome in Esophageal Atresia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Abnormal glycaemia associated with vagal hypertonia
研究概览
简要总结
Dumping syndrome (DS) is frequent in oesophageal atresia (29%). In causing hypoglycaemia, it can be dangerous for neonates. Mechanisms of DS are actually partialy understood. This is also an affection difficult to diagnose, because it only occurs after meals and can be inconstantly present. To date, their is only symptomatic treatment for DS. This study aims to understand its pathological mechanisms so as to better treat it and avoid its consequences. Oesophageal atresia patients enrolled in this study will benefit from a continuous glycemic monitoring, a continuous cardiac monitoring, and an a gastric emptying scintigraphy at the age of 3 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients operated at birth for Oesophageal atresia type C
- •Aged from 2 to 3 months at inclusion
- •Off prokinetic treatment (suspended for at least 72 hours) before monitoring
排除标准
- •History of dumping syndrome of other cause (microgastria, fundoplication, dysautonomia..)
- •History of any disease that can modify glycemic regulation (hyperinsulinism, neonatal diabete)
- •Treatment that can modify gastric motility
结局指标
主要结局
Abnormal glycaemia associated with vagal hypertonia
时间窗: At least once during the 48 hours monitoring
Composite criteria: association between abnormal glycaemia (high or low) and variations of cardiac frequency
次要结局
- Tolerance of glucose monitoring(At least once during the 48 hours monitoring)
- Abnormal glycaemia associated with abnormal gastric emptying(At least once during the 48 hours monitoring)
- Persistance of dumping syndrome(At the age of 6 months)