CTRI/2019/05/019197已完成3 期
Phase III, multicentre, randomized, double-blind, placebo-controlled study to evaluate efficacy of probiotic supplementation for prevention of neonatal sepsis in 0-2 months old low birth weight infants in India
Indian Council of Medical Research Hqrs0 个研究点目标入组 6,144 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6,144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Birth weight: =1500 g to =2500 g
- •2. Age of the new-born Day 3-7 on recruitment i.e. not later than 7th day
- •3. Stable clinical condition as assessed by physician and accepting feeds orally (where stable is defined as, does not require intravenous fluids and vasopressor medication to maintain circulation and accepts oral feeding or breastfeeding).
- •4. The mother (with the new-born) is planning to stay in study area for a period of at least two months
排除标准
- •1. New born with extreme prematurity i.e. = 34 weeks
- •2. New born with illness requiring prolonged hospitalisation and interference with oral feeding
- •3. Presence of a gross congenital malformation incompatible with life
- •4. Parent or Legally authorized representative (LAR) not providing written consent
研究者
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