A Multi-center, Double-blind, Randomized, Three-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 300
- 试验地点
- 50
- 主要终点
- Numbers of Days to Achieve Complete Enteral Feeding
研究概览
简要总结
The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.
详细描述
The study will assess the efficacy and safety of NTRA-2112 on intestinal malabsorption in preterm infants as compared to placebo
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
- 1 Day 至 5 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
NTRA-2112 A
NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.
干预措施: NTRA-2112 (Drug)
NTRA-2112 B
NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.
干预措施: NTRA-2112 (Drug)
Placebo
Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.
干预措施: Placebo (Drug)
结局指标
主要结局
Numbers of Days to Achieve Complete Enteral Feeding
时间窗: 28 days or discharge from hospital
Numbers of days to achieve full enteral feeding (NFE) is defined as: Number of Days to the first day of achieving enteral feeding of at least 150 ml/kg/day, which must be sustained for at least 3 consecutive days.
次要结局
- Number of Days to Achieve Discharge From Hospital or Readiness to Discharge(28 days or discharge from hospital)