CTRI/2024/01/062023尚未招募不适用
To study the effect of probiotics preparation Infloran® supplementation in on morbidities in Indian preterm neonates (PrISM)
Dr Nandini Desai Principle1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年2月25日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- suspected or confirmed positive Bell state II or more (1)(2)
研究概览
简要总结
Preterm infants born at the study site hospitals or referred to these hospitals will be enrolled in the study, if they satisfy all inclusion criteria and meet none of the exclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Day(s) 至 7.00 Day(s)（—）
入选标准
- •Gestation: Preterm infants and neonates born at 32 weeks gestation or 32 to 36 weeks gestation Age at recruitment: within 7 days of age Weight: very low birth weight or lessthan 1500 grams Gender any.
排除标准
- •Severe birth complications Malformation of the gut (omphalocele, gastroschisis, intestinal atresia) Chromosomal anomalies Neonates with central venous catheter Neonates on antifungal drugs.
结局指标
主要结局
suspected or confirmed positive Bell state II or more (1)(2)
时间窗: Day 42 after the birth
次要结局
- Culture positive sepsis: blood culture positive(Clinical sepsis: clinical features of sepsis without positive blood culture)
- All-cause mortality(Day 42 after the birth)
研究者
Dr Bhadresh R Vyas
M P Shah Medical College and G G Hospital, Jamnagar
研究点 (1)
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