Double-blind, Randomized, Placebo-controlled Clinical Trial to Assess the Efficacy and Safety of R051619 (Cisapride Oral Suspension 0.2mg/kg q.i.d) for the Treatment of Feeding Intolerance in Premature Infants
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 8
- 主要终点
- Time from start of study medication to full enteral feeding
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of Cisapride in improving feeding problems in premature newborn infants.
详细描述
This is a double-blind study where the identity of the treatment assigned (Cisapride or placebo) will not be known to the patient's legal guardian or any study staff involved with the study. Patients will be randomized (assigned by chance) to receive either the drug Cisapride or a placebo (a placebo is identical in appearance to Cisapride but does not contain Cisapride or any active drug) to see if Cisapride is effective in improving feeding problems (referred to as feeding intolerance) in premature newborn infants who cannot tolerate oral feeding by mouth or through a tube going directly to the stomach or intestine. Patients will be given either cisapride at a dose of 0.2 mg/kg or placebo as a liquid suspension through a tube from the nose to the stomach (referred to as a nasogastric tube) 15 minutes before feeding once every 6 hours (or 4 times a day referred to as a q.i.d. schedule).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 36 Weeks 至 99 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be hospitalized and on continuous cardiac monitoring for the duration of the study
- •Patient has demonstrated feeding intolerance as defined by the protocol
- •Patient's parent or legal guardian must sign the informed consent form
排除标准
- •Currently active significant cardiovascular disease, as determined by the neonatologist/physician, including congenital heart disease and heart block (patent ductus arteriosus without cardiac compromise at the time of randomization is acceptable)
研究组 & 干预措施
001
Cisapride 0.2 mg/kg liquid suspension 4 times a day (q.i.d.) for up to 42 days
干预措施: Cisapride (Drug)
002
Placebo liquid suspension identical in appearance to Cisapride 4 times a day (q.i.d.) for up to 42 days
干预措施: Placebo (Drug)
结局指标
主要结局
Time from start of study medication to full enteral feeding
时间窗: Up to 42 days
次要结局
- Number and type of adverse events(Up to 42 days)