CTRI/2024/07/069824已完成4 期
To study the effect of probiotics Supplementation on Morbidities in Indian Preterm Neonates.
RNT Medical College & Hospital, Udaipur1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年7月15日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- suspected or confirmed positive Bell stage 2 or more
研究概览
简要总结
Probiotic supplementation in preterm neonates was safe and associated with modest improvements in weight at discharge and follow-up. However, it did not significantly impact NEC, sepsis, mortality, or hospital stay, with gestational age remaining the strongest predictor of outcomes. Probiotics can be safely incorporated into NICU care for preterm neonates to support growth, but their greatest benefit is likely in extremely preterm and high-risk populations.
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)（—）
- 性别
- All
入选标准
- •Gestation Neonates born before less than 34weeks Age at recruitment within 7 days of life Weight low birth weight less than 1800 grams.
排除标准
- •Malformation of the gut (omphalocele, gastroschisis, intestinal atresia) Neonates with central venous catheter Any condition that prevents oral or nasogastric intake.
结局指标
主要结局
suspected or confirmed positive Bell stage 2 or more
时间窗: Everyday until the period of hospital stay and further upto 6 weeks of life
次要结局
- Culture positive sepsis: blood culture positive(Clinical sepsis: clinical features of sepsis without)
研究者
Dr Nehal Athreyi R
RNT Medical College & Hospital, Udaipur
研究点 (1)
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