Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate.
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Blood culture
研究概览
简要总结
Hypothesis:
Orally ingested lactoferrin has effects on promotion of growth and differentiation of the immature gut; also it has immunomodulatory properties, so it will prevent serious infections in preterm infants.
The aim of the study is to:
- Evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis.
- Compare two dose regiment of lactoferrin supplementation.
- Study effect of lactoferrin supplementation on serum iron stores.
It is a prospective, randomized, double blind, placebo-controlled study, it will include 180 preterm neonates admitted to the Neonatal Intensive Care Units of of Ain Shams University Hospitals and Manshiet El Bakry Hospital.
•Group A: Who will receive oral lactoferrin supplementation in a dose of 100 mg/day.
•Group B: Who will receive oral lactoferrin supplementation in a dose of 150 mg/kg/ twice daily.
•Group C (Controls): Who match the subjected neonates, will receive placebo in form of distilled water.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Neonates with a birth weight between 500g and 2500g.
- •Neonates with a ≤ 36 weeks of gestation counting from the first day of the Last Menstrual Period.
- •Preterm neonates born in, or referred to the Neonatal Intensive Care Units of one of the participating hospitals in the first 48 hours of life.
排除标准
- •Neonates with underlying gastrointestinal problems that prevent oral intake.
- •Neonates with predisposing conditions that profoundly affect growth and development (chromosomal abnormalities, structural brain anomalies, severe congenital abnormalities).
- •Neonates with a family background of cow milk allergy.
- •Neonates who will not have the chance to complete the study time (who will be referred to another hospitals).
- •Neonates whose parents decline to participate.
- •Neonates with early onset sepsis.
结局指标
主要结局
Blood culture
时间窗: 2 years
次要结局
- Complete blood count with differential leucocytic count.(2 years)
研究者
Mostafa El-Mokadem
neonatologist
Mooselmokadem