跳至主要内容
临床试验/CTRI/2018/01/011079
CTRI/2018/01/011079招募中4 期

A prospective, open label study to determine the effectiveness of probiotics in prevention of necrotizing enterocolitis in preterm admitted in tertiary care centre nicu, pediatric department sir t. Hospital, bhavnagarâ€ADMITTED IN TERTIARY CARE CENTRE NICU, PEDIATRIC DEPARTMENT SIR T. HOSPITAL, BHAVNAGARâ€

Department of Pediatrics Bhavnagar1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年9月28日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
No occurrence of necrotisinig enterocolitis

研究概览

简要总结

NECROTIZING ENTEROCOLITIS (NEC) is preterm neonate is a major cause of mortality and morbidity. with the use of probiotics we can minimize the occurrence ofNEC and can reduce subsequent events.i will be choosing high risk  preterm newborns for my study.in 50% of neonate i will be giving probiotics and will keep rest50% without it and will be studyingoccurrenceof changes of NEC in both the groups.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
1.00 Day(s) 至 30.00 Day(s)(—)
性别
All

入选标准

  • Preterm baby 1.gestational age 28 to 34 weeks 2.Birth weight of ≤ 2kg.

排除标准

  • Preterm newborn 1.Birth weight>2kg 2.Lethal Congenital malformation 3.Newborn on ventilator.

结局指标

主要结局

No occurrence of necrotisinig enterocolitis

时间窗: after 7 days of introducing probiotics

次要结局

  • No occurrence of necrotisinig enterocolitis(06 months)

研究者

发起方
Department of Pediatrics Bhavnagar
申办方类型
Government medical college

研究点 (1)

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