The Role of Lactobacillus Reuteri (L. Reuteri) in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants Less Than 34 Weeks of Gestation
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 主要终点
- narcotizing enterocolitis
研究概览
简要总结
The purpose of this study is to compare the effectiveness of L. Reuteri with placebo in prevention of NEC in children, as according to my knowledge, there is limited work is done nationally and internationally. Probiotics are being used in our Children Hospital and the Institute of Child Health, Multan.
Route of administration of L. Reuteri will be oral or via nasogastric tube due to availability of oral form in Pakistan. The results of this study will be helpful to assess the beneficial effects of probiotics especially L. Reuteri in NEC in preterm. So, they can be recommended as preventive strategy to avoid NEC development and its complications based on its availability, effectivity and easy administration
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 28 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm neonate< 34 weeks and >28 weeks of gestation of both genders Hemodynamically stable
排除标准
- •Preterm neonates >34 weeks gestational age < 28 weeks of gestation Cardiorespiratory illness Parental refusal
研究组 & 干预措施
drug group
The trial group will receive their usual feeds plus daily probiotic (Lactobacillus Reuteri DSM 17938) addition 1 drop/kg/dose(. minimum of 20 million live Lactobacillus Reuteri are present in One drop) twice daily added in expressed breast milk/formula milk from the beginning of enteral feedings till the baby attain full feeds
干预措施: Lactobacillus Reuteri DSM 17938 (Drug)
control group
this group is control group and will receive normal saline drops as 1 drop/kg/ dose mixed in enteral feed
干预措施: Placebo (Drug)
结局指标
主要结局
narcotizing enterocolitis
时间窗: up to 35 weeks of gestation
number of participants with the sign of feeding intolerance (such as the gastric aspirate in the amount that was more than half of previous feeding), or with abdominal distension measured by increase in abdominal girth from base line,Bell Staging Criteria according to clinical and radio-logical signs
次要结局
- sepsis(At time of addmission and 15 days after intervention)
研究者
Dr Summera Tabasum
post-graduate resident
Children's Hospital and Institute of Child Health, Multan