Frequency of Occurrence of Dumping Syndrome After Operation of Esophageal Atresia Type III
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 10
- 主要终点
- Early hyperglycemia during Oral Glucose Tolerance Test (OGTT)
研究概览
简要总结
The purpose of this study is to evaluate the prevalence at 3.5 months of age of dumping syndrome in children operated at birth for oesophageal atresia type III et IV.
详细描述
Consecutive patients with type III and IV oesophageal atresia that are born in 8 different centers in France and Sydney (Australia) are included in the study, if willing. As soon as they weigh more than 4.150kg and if they are still younger than 3.5 months, an Oral Glucose Tolerance Test (OGTT) is performed. Glycemia and insulinemia are monitored every 30 minutes from intake to 240 minutes. Clinical signs that are presented are noted. If early hyperglycemia or late hypoglycemia are biologically or clinically observed, ascarbose treatment is initiated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 14 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New born less than 3.5 months or age corrected for premature new born
- •Weight ≥ 4, 150 kg
- •Esophageal atresia (EA) type III or IV
- •EA Surgery between May 2013 and June 2016
- •Stop of prokinetic treatment > 72 h before OGTT
- •Information and consent of parents
- •Patients with health insurance
排除标准
- •Age > 3.5 months
- •Weight < 4.150 kg
- •Other types of EA
- •Dumping syndrom from other origin: microgastria, dysautonomia, small intestine surgery
- •Other pathology that can modify glycemia: neonatal diabete, hyperinsulinism
- •Treatment that can modify gastric motility: domperidone, erythromycin, baclofen that hasn't been stopped in the 72h before OGTT
- •Absence of consent
- •Patient judiciary protected
- •Simultaneous participation to another clinical trial
- •No health insurance
研究组 & 干预措施
Every EA patients
This is a one group interventional study. Every patient is included in the same arm.
干预措施: Oral Glucose (Biological)
结局指标
主要结局
Early hyperglycemia during Oral Glucose Tolerance Test (OGTT)
时间窗: up to 240 min
Hypoglycemia : glycemia \< 0,6 g/L
Late hypoglycemia during OGTT
时间窗: up to 240 min
Hyperglycemia : \> 1,8g/L from H0 to 30 min after oral intake, \> 1.7 between 1 and 2 h ours, \> 1.4 between 2 and 3 h , \> 1, 26 after 3 h
次要结局
- Clinical signs presenting consequently to OGTT(continuous monitoring during 240 minutes)
- Associated pathologies(1 day)
- Surgery details(1 day)
- Post-surgery complications(1 day)