Assessing the Efficacy of Probiotics in Prevention of NEC in Preterm Babies
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Number of participants who develop NEC on probiotic vs placebo
研究概览
简要总结
The goal of the study is to check efficacy of probiotics in preventing necrotizing enterocolitis. The main questions would be if the preterm baby developed NEC or not.
详细描述
: In the last five years, many systematic reviews have shown the benefit of Probiotics in prevention of NEC and Sepsis in preterm babies but most of these studies have been done in the developed countries. Although the overall benefit has been tilted In favor of use of probiotic however a definitive consensus has not been reached due to inconsistencies in results. Moreover, the impact of multistrain probiotics in our particular population has not been studied, which provides the rationale for our research
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female preterm infants with a gestational age less than 35 weeks.
- •All indoor patients and outdoor patients who present within 24hrs of birth
排除标准
- •• Infants with congenital or developmental gastrointestinal disorders for example omphalocele, malrotation, gastroschisis.
- •Infants with severe sepsis or gastrointestinal bleeding on presentation
研究组 & 干预措施
Placebo
This group will receive 10% DW
干预措施: 10% dextrose (Drug)
Probiotic group - Intervention
This group will receive intervention
干预措施: Probiotic (Drug)
结局指标
主要结局
Number of participants who develop NEC on probiotic vs placebo
时间窗: 30 days
次要结局
未报告次要终点