Role of prophylactic probiotics in prevention of necrotising enterocolitis and sepsis in premature neonates
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- In preterm low birth weight babies
研究概览
简要总结
We compared the efficacy of prophylactic probiotics versus no treatment in prevention of necrotising enterocolitis and nosocomial sepsis in premature ( less than 35 weeks gestation ) , LBW infants (less than 2 kg weight )
Secondary outcomes to be measured are duration of hospitalization, time to establish full feeds , mortality and episodes of feed intolerance.
We excluded infants who had sepsis, severe congenital malformation , were severely small for gestational age, had immunodeficiency or had severe asphyxia .
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 2.00 Day(s) 至 30.00 Day(s)（—）
- 性别
- All
入选标准
- •All infants admitted to our nicu with birth weight less than 2 kg or gestational age less than 35 weeks as assessed by EDD and further confirmed by Ballards score who survive the first 24 hrs of life will be enrolled in the study.
排除标准
- •Major congenital anomalies
- •Severe asphyxia
- •Severe IUGR
- •Immunocompromised host like hiv infected infants.
结局指标
主要结局
In preterm low birth weight babies
时间窗: 1st of june 2018
To compare the safety and efficacy of prophylactic probiotics versus no treatment in prevention of
时间窗: 1st of june 2018
1.Necrotising colitis
时间窗: 1st of june 2018
2. Nosocomial sepsis
时间窗: 1st of june 2018
次要结局
- 1. Duration of hospitalization(2. Time to establish full feeds)