A Prospective, Randomized, Double-blind Crossover Study Comparing 0.15 g/L rhBSSL Added to Pasteurized Breast Milk Versus Placebo During One Week of Treatment in Preterm Infants Born Before Week 32 of Gestational Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 8
- 主要终点
- Coefficient of Fat Absorption measured in stool
研究概览
简要总结
The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in pasteurized breast milk.
详细描述
In this double-blind crossover study, patients will be randomized to receive pasteurized breast milk including BSSL or pasteurized breast milk without BSSL for the first 7 days. After a wash-out period of 2 days the patients will "crossover" to the other treatment regimen and receive an additional 7 days treatment. The primary efficacy measurements will be made by collecting stool during the last three days of each treatment period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants
- •less than or equal to 32 weeks of gestational age
- •appropriate for gestational age
- •enterally fed with pasteurized breast milk
排除标准
- 未提供
研究组 & 干预措施
rhBSSL
干预措施: rhBSSL (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Coefficient of Fat Absorption measured in stool
时间窗: Stool collected for a 72-hour period during the final 3 days of each treatment period
次要结局
- Change in length and body weight(Baseline and after one week of treatment)