Fixed versus symptom based duration of antibiotics in probable Early onset neonatal sepsis An open label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Antibiotic utilization ratio for early onset sepsis
研究概览
简要总结
Our study is planning to address this knowledge gap by comparing the symptom based course of antibiotics based upon symptom resolution in cases being managed as clinically suspected early onset sepsis in neonates versus fixed course of a minimum of 5-7 days. We shall be both looking at clinically relevant outcomes and comparing adverse events in both the groups.Among neonates with completed gestational age at birth ≥32 weeks and birth weight ≥1500gm with early onset neonatal sepsis (P), does symptom based course of antibiotics (I) in comparison to fixed course(C), reduces the antibiotic utilization ratio (O) in clinically suspected early onset sepsis during hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Day(s) 至 5.00 Day(s)（—）
- 性别
- All
入选标准
- •Inborn neonates with gestational age ≥ 32 week and birth weight ≥1500gm with maternal and neonatal factors at birth will be assessed for eligibility for persistence of symptoms at 48-72 hours and negative blood culture.
排除标准
- •Severe birth asphyxia, IVH, PICC/UVC,bleeding, meningitis, other sepsis trial.
结局指标
主要结局
Antibiotic utilization ratio for early onset sepsis
时间窗: At end of first week of life
次要结局
- 1.Clinical deterioration during(intervention period of 7 days)
研究者
Shiwani Thakur
Government Medical College and Hospital