NCT01093638终止2 期
A Multi-center, Randomized, Double-blinded Clinical Study to Assess the Effect of Insulin Enriched Formula on Gastrointestinal Tract Maturation in Pre-term Infants.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Number of days to achieve complete enteral feeding
研究概览
简要总结
The study will evaluate the effect of oral formulation of insulin on preterm infants, born between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and exclusion criteria established in this protocol.
详细描述
The study will aim to determine whether an oral formulation of insulin administration enhances gastrointestinal maturation. The gastrointestinal maturation will be evaluated by the ability of premature infants to achieve complete enteral feeds. The insulin concentration administered in the study is physiological and within the insulin concentration range present in human breast milk and colostrum.
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
- 26 Weeks 至 33 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pre-term infants 26-33 weeks gestation.
排除标准
- 未提供
结局指标
主要结局
Number of days to achieve complete enteral feeding
时间窗: Up to 28 days or discharge and at 3 months of age
次要结局
- Number of days to discharge(Up to 28 days or discharge and at 3 months of age)
- Number of gastric residual > 2 ml/kg(Up to 28 days or discharge, at 3 months of age)
- Number of gastric residual > 50% of previous feeding(Up to 28 days or discharge and at 3 months of age)
- Weight gain(Up to 28 days or discharge and at 3 months of age)
研究者
研究点 (2)
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