The Effects of Lactulose Supplementation to Enteral Feedings in Premature Infants - A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- lactulose would support the early growth of Lactobacilli in the stools of premature infants
研究概览
简要总结
A pilot study to test the safety of use of lactulose in preterm infants and to preliminary assess the hypothesis that lactulose would support the early growth of Lactobacilli in the stools of premature infants and possibly would also improve nutritional status and decrease NEC and late-onset sepsis.
详细描述
Prospective, double-blind, placebo-controlled single center pilot study in 23-34 weeks gestation premature infants. Study group will receive 1% lactulose, while control group will receive 1% dextrose placebo in all their feeds (human milk or preterm formula). Clinical parameters will be followed. Stool samples will be sent for culture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 23 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infants were recruited based on the following criteria:
- •23-34 weeks' gestation (as determined by a combination of maternal dates, early prenatal ultrasonography and postnatal gestational age estimation based on physical and neuromuscular signs (New Ballard Score), as long as there will be gestational age agreement between the 3 methods < 2 weeks);
- •Absence of major congenital malformations; and
- •Informed consent obtained from parents.
排除标准
- •Major congenital malformations and parental refusal.
研究组 & 干预措施
1
Study group will receive 1% lactulose in all their feeds (human milk or preterm formula)
干预措施: Lactulose (Drug)
2
Control group will receive 1% dextrose placebo in all their feeds (human milk or preterm formula).
干预措施: Dextrose (Dietary Supplement)
结局指标
主要结局
lactulose would support the early growth of Lactobacilli in the stools of premature infants
时间窗: 1.5 years
次要结局
- lactulose would also improve nutritional status and decrease NEC and late-onset sepsis in preterm infants(1.5 years)