Effectivness and Safety of Oral Bovine Lactoferrin in Neonatal Sepsis and Necrotizing Enterocolitis and Its Effect on Anaemia of Prematurity
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in mortality rate of neonatal sepsis in preterm neonate
研究概览
简要总结
Oral lactoferrin versus Placebo will be given to preterm neonates
详细描述
200 patient were included in the study , one hundred received oral placebo in the form of 2 ml saline , the other 100 preterm neonates received oral lactoferrin with monitoring of C-reactive protein , different cultures, complete blood count on day 7 and after one month.
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
- Single (Investigator)
盲法说明
Follow up of the patients with CRP and different cultures.
入排标准
- 年龄范围
- 1 Day 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All neonates born at Cairo university hospital NICU
排除标准
- •Neonatal deaths before 3 days postnatal .
- •Neonates with underlying gastrointestinal problems that prevent oral intake.
- •Neonates with major congenital anomalies .
- •Neonates with severe hypoxic ischemic encephaloapathy .
- •Neonates whose parents refuse to participate.
研究组 & 干预措施
lacoferrin
Pravotin is given orally 100 mg per sachet dissolved in 5 ml water given for one month
干预措施: Lactoferrin (Drug)
placebo
saline is given orally in dose of 2 ml per day for one month
干预措施: Placebos (Drug)
结局指标
主要结局
Change in mortality rate of neonatal sepsis in preterm neonate
时间窗: one year
Neonates will be assessed by C-reactive protein and different cultures to identify Neonatal sepsis
Number of Preterm Neonates who will have long term Complication after one month of regular use of Lactoferrin
时间窗: one year
Neonates will be assessed for long term complication as necrotizing enterocolitis , retinoapathy of prematurity and bronchopulmonary dysplasia
次要结局
未报告次要终点
研究者
ayman zaher
Resident of Pediatrics
Cairo University