NCT05670951招募中3 期
A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Numbers of days to achieve full enteral feeding
研究概览
简要总结
The study will evaluate the effect of ELGN-2112 on intestinal malabsorption in preterm infants.
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
- •Male or female pre-term infant 26 and up to 32 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound
- •Birth weight ≥ 500g
- •Singleton or twin birth
排除标准
- 未提供
研究组 & 干预措施
ELGN-2112
Active Comparator
干预措施: ELGN-2112 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Numbers of days to achieve full enteral feeding
时间窗: 28 days or discharge from hospital
次要结局
未报告次要终点
研究者
研究点 (1)
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