A Clinical Multi-Center Study of Efficacy Analysis in Different Doses of Domperidone in Feeding Intolerance of Premature Infant
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- the residual glucose percentage
研究概览
简要总结
The purpose of this clinical multi-center study is to determine whether different doses of domperidone are effective in the treatment of feeding intolerance in premature infant
详细描述
the premature infant have been divided into four group.The first group take the 0.2mg/kg/tds domperidone as treatment ,while the other group take the 0.4mg/kg/tds domperidone,0.6mg/kg/tds domperidone and the placebo respectively .
An objective index has been decided to evaluate the severity of feeding intolerance in the premature infant. 3kg/kg 5% glucose will be injected into the gastric tube .The residual glucose will be drawed out from the gastric tube. The residual percentage is the main result of the study.
The main result will be compared by the secondary result to help to explain the accuracy. The secondary result is the percentage of residual milk drawed out from the gastric tube from how many milk the infant take 3 hours ago.
Any adverse effect will be recorded and analysed to figure out whether is associate with the domperidone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Weeks 至 35 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the residual milk and glucose over 55%
- •abdominal distention or vomiting;
- •Reduce,delay or disruption of enteral feeding
排除标准
- •Four weeks before the start of this study had participated in other clinical trials
- •pulmonary hypertension;
- •Infants with necrotizing enterocolitis
- •Gastrointestinal tract malformation, congenital heart disease
- •Pre-existing QT extend/between long QT syndrome;
- •Have been used or will use drugs suppress CYP3A4
- •Other risk factors for prolong the QT
研究组 & 干预措施
low dose
The premature infant in this group will be feed with 0.2mg/kg/tds domperidone suspension(motilium;100ml)for 7 days and will be tested the residual percentage everyday.
干预措施: Low dose (Drug)
normal dose
The premature infant in this group will be feed with 0.4mg/kg/tds domperidone suspension(motilium;100ml)for 7 days and will be tested the residual percentage everyday.
干预措施: normal dose (Drug)
over dose
The premature infant in this group will be feed with 0.6mg/kg/tds domperidone suspension(motilium;100ml)for 7 days and will be tested the residual percentage everyday.
干预措施: over dose (Drug)
placebo
The premature infant in this group will be feed with some vitamin which will dilute into the 5% glucose and have the same appearance and taste with the experimental team for 7 days and will be tested the residual percentage everyday.
干预措施: Glucose (Drug)
结局指标
主要结局
the residual glucose percentage
时间窗: 7 days
3kg/kg 5% glucose will be injected into the gastric tube .The residual glucose will be drawed out from the gastric tube after 30 min
次要结局
- the percentage of residual milk(7 days)
研究者
Weimin Huang
The director of the neonatology department
Nanfang Hospital, Southern Medical University