NCT02731092Unknown1 期
Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Definitely related study solution serious adverse event
研究概览
简要总结
To evaluate the safety and tolerability of three different lactoferrin doses in preterm infants
详细描述
Aim1: To evaluate the safety and tolerability of three different lactoferrin doses in preterm infants
- Lactoferrin related adverse events and serious adverse events
- Number of infants reaching full feeds while receiving lactoferrin (120 ml/kg/day)
- Episodes of not receiving enteral feedings for > 24 hours once feeding is initiated
Aim 2: To evaluate lactoferrin absorption and excretion.
- Examine lactoferrin levels in saliva, urine, plasma and stool
- Examine lactoferrin levels in maternal and human donor milk.
Aim 3: To evaluate the effect of lactoferrin on the intestinal microbiome structure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •< 15 days of age and receiving enteral feedings
- •< 1500 grams birth weight
- •<37 weeks gestation
排除标准
- •Congenital bowel obstruction ( esophageal, duodenal, small bowel or anal atresias, Hirschsprung disease, malrotation)
- •Known necrotizing enterocolitis or bowel perforation
研究组 & 干预措施
Lactoferrin 100 mg/kg
Experimental
100 mg/kg enteral administration daily for 30 days
干预措施: Lactoferrin (Dietary Supplement)
Lactoferrin 300 mg/kg
Experimental
300 mg/kg enteral administration daily for 30 days
干预措施: Lactoferrin (Dietary Supplement)
Lactoferrin 200 mg/kg
Experimental
200 mg/kg enteral administration daily for 30 days
干预措施: Lactoferrin (Dietary Supplement)
结局指标
主要结局
Definitely related study solution serious adverse event
时间窗: 30 days while receiving study solution
次要结局
- Number of infants reaching 120 ml/kg of enteral feeds(30 days while receiving study solution)
- Number of days not receiving any feedings after lactoferrin administration(30 days while receiving study solution)
研究者
David A Kaufman
MD
University of Virginia
研究点 (2)
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