NCT03163212Unknown早期 1 期
Safety and Tolerability of Lactoferrin/FOS in Very Low Birth Weight Infants
适应症
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 20
- 主要终点
- Definitely related study solution serious adverse event
研究概览
简要总结
This study will examine the safety and tolerability of supplementation with bovine lactoferrin with fructo-oligosaccharide a simple sugar in very low birth weight infants. Lactoferrin is a major whey protein in mother's milk and plays a role in promoting a mature and healthy gut. It also has antimicrobial and immunomodulation activities.
详细描述
Aim 1: To evaluate the safety and tolerability of three different lactoferrin/FOS doses in preterm infants
- Lactoferrin/FOS related adverse events and serious adverse events
- Time reaching full feeds while receiving lactoferrin/FOS (120 ml/kg/day)
- Episodes of not receiving enteral feedings for > 24 hours once feeding is initiated
Aim 2: To evaluate lactoferrin/FOS absorption and excretion
- Examine lactoferrin/FOS levels in saliva, urine, plasma, and stool
- Examine lactoferrin levels in materal and human donor milk
Aim 3: To evaluate the effect of lactoferrin/FOS on the intestinal microbiome structure
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
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
- Day after birth to reach 120ml/kg of enteral feeds(30 days while receiving study solution)
- Number of days not receiving any feedings after lactoferrin/FOS administration(30 days while receiving study solution)
研究者
David A Kaufman
Neonatologist
University of Virginia
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