Use of Zinc and Pre-Probiotics as a therapeutic adjunct in neonatal sepsis in preterms- An Open label randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Reduction in Mortality
研究概览
简要总结
RESULTS:
A total of 124 newborns had provensepsis during the study period and all were randomised. Of 124, zinc group had32, pre-probiotics had 32, zinc and pre-probiotics had 29 and control group had31 cases. None of the cases were discharged AMA. No adverse effectreported in any intervention group.
In this study, we found baselinecharacteristics were similar in all four groups (p>0.05).
When the final outcome in all four groupswere compared, we found significantly decrease in mortality in zincand pre-probiotics group (p=0.04).Also, there is significant decrease in need for higher antibiotics in the same(p=0.02). But need for supportivetreatment and duration of hospital stay did not differ significantly in anygroup as compared with control (p>0.05).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Day(s) 至 30.00 Day(s)（—）
- 性别
- All
入选标准
- •All intramural preterm neonates from 28wk1day to 36wk6days admitted to NICU at GMCH Aurangabad with proven sepsis during the study period, whose parents consented to be part of the study were included.
- •Diagnostic criteria for sepsis was (a) Positive ‘sepsis screen’ i.e. presence of at least two of the following three parameters, namely, Total leucocyte count <5000/mm3, Low absolute neutrophil count (as per standard charts), C-reactive protein>1mg/dl, (b) Radiological evidence of pneumonia (c) Culture positive sepsis (d) Meningitis.
排除标准
- •Parental refusal to consent, neonates < 28 weeks GA, severe birth asphyxia, life threatening congenital malformations, critically ill newborns within 24 hours of life, neonates with necrotizing enterocolitis.
结局指标
主要结局
Reduction in Mortality
时间窗: at discharge/30 days of life
次要结局
- Duration of hospital stay(At discharge/ 30 days of life)
- Need for change to higher (2nd/3rd line) antibiotics(At discharge/ 30 days of life)
- Need for supportive treatment i.e ventilation, inotropes, blood transfusion(At discharge/ 30 days of life)